Trial Outcomes & Findings for Decision Aid for Education and Support About Cancer Treatment (NCT NCT06191679)
NCT ID: NCT06191679
Last Updated: 2025-01-06
Results Overview
This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
8 weeks post-randomization
Results posted on
2025-01-06
Participant Flow
* Potential participants were identified through outpatient oncology appointment and inpatient oncology unit lists at a single academic medical center between August 2020 and January 2023. * Adolescent and young adults (AYA) enrolled with a maximum of 2 caregivers, and those 18 or older could consent to participate independently. * Oncology clinicians were recruited to participate in an interview only; they were not randomized and did not complete assessments or provide demographics.
* n=117 (57 AYA, 47 Caregivers, 13 Oncology Clinicians) enrolled. * n=13 Oncology Clinicians were NOT randomized or administered a Baseline or Post-Intervention Assessment (per protocol). * n=7 (4 AYA, 3 Caregivers) were NOT randomized because they withdrew before randomization. * n=97 (53 AYA, 44 Caregivers) were randomized
Participant milestones
| Measure |
Usual Care
Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual).
|
DECIDES With Informational Handout (DECIDES)
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
Oncology Clinicians
Oncology Clinicians of participating AYA are not randomized to an intervention arm.
|
|---|---|---|---|---|
|
Baseline
STARTED
|
21
|
35
|
41
|
0
|
|
Baseline
Started (AYA)
|
11
|
21
|
21
|
0
|
|
Baseline
Started (Caregivers)
|
10
|
14
|
20
|
0
|
|
Baseline
Completed (AYA)
|
10
|
21
|
20
|
0
|
|
Baseline
Completed (Caregivers)
|
10
|
14
|
20
|
0
|
|
Baseline
COMPLETED
|
20
|
35
|
40
|
0
|
|
Baseline
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Allocation to Group
STARTED
|
21
|
35
|
41
|
0
|
|
Allocation to Group
Started (AYA)
|
11
|
21
|
21
|
0
|
|
Allocation to Group
Started (Caregivers)
|
10
|
14
|
20
|
0
|
|
Allocation to Group
Completed (AYA)
|
11
|
20
|
20
|
0
|
|
Allocation to Group
Completed (Caregivers)
|
10
|
14
|
19
|
0
|
|
Allocation to Group
COMPLETED
|
21
|
34
|
39
|
0
|
|
Allocation to Group
NOT COMPLETED
|
0
|
1
|
2
|
0
|
|
Post-Intervention Assessment
STARTED
|
21
|
34
|
39
|
0
|
|
Post-Intervention Assessment
Started (AYA)
|
11
|
20
|
20
|
0
|
|
Post-Intervention Assessment
Started (Caregiver)
|
10
|
14
|
19
|
0
|
|
Post-Intervention Assessment
Completed (AYA)
|
10
|
18
|
20
|
0
|
|
Post-Intervention Assessment
Completed (Caregiver)
|
9
|
13
|
19
|
0
|
|
Post-Intervention Assessment
COMPLETED
|
19
|
31
|
39
|
0
|
|
Post-Intervention Assessment
NOT COMPLETED
|
2
|
3
|
0
|
0
|
|
Post-Intervention Qualitative Interview
STARTED
|
0
|
31
|
39
|
13
|
|
Post-Intervention Qualitative Interview
Started (AYA)
|
0
|
18
|
20
|
0
|
|
Post-Intervention Qualitative Interview
Started (Caregiver)
|
0
|
13
|
19
|
0
|
|
Post-Intervention Qualitative Interview
Completed (AYA)
|
0
|
15
|
18
|
0
|
|
Post-Intervention Qualitative Interview
Completed (Caregiver)
|
0
|
9
|
16
|
0
|
|
Post-Intervention Qualitative Interview
COMPLETED
|
0
|
24
|
34
|
11
|
|
Post-Intervention Qualitative Interview
NOT COMPLETED
|
0
|
7
|
5
|
2
|
Reasons for withdrawal
| Measure |
Usual Care
Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual).
|
DECIDES With Informational Handout (DECIDES)
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
Oncology Clinicians
Oncology Clinicians of participating AYA are not randomized to an intervention arm.
|
|---|---|---|---|---|
|
Baseline
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Allocation to Group
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Post-Intervention Assessment
Lost to Follow-up
|
2
|
3
|
0
|
0
|
|
Post-Intervention Qualitative Interview
Lost to Follow-up
|
0
|
7
|
5
|
0
|
|
Post-Intervention Qualitative Interview
Started but did not finish due to time constraints.
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
Baseline characteristics by cohort
| Measure |
Usual Care
n=21 Participants
Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual).
|
DECIDES With Informational Handout (DECIDES)
n=35 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=41 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
AYA · <=18 years
|
7 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
13 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
13 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
33 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Categorical
AYA · Between 18 and 65 years
|
4 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
8 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
8 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
20 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Categorical
AYA · >=65 years
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Categorical
Caregivers · <=18 years
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Categorical
Caregivers · Between 18 and 65 years
|
9 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
14 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
20 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
43 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Categorical
Caregivers · >=65 years
|
1 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Continuous
AYA
|
17.3 years
STANDARD_DEVIATION 2.0 • n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17.7 years
STANDARD_DEVIATION 1.4 • n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17.5 years
STANDARD_DEVIATION 1.9 • n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17.5 years
STANDARD_DEVIATION 1.7 • n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Age, Continuous
Caregivers
|
47.0 years
STANDARD_DEVIATION 11.3 • n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
47.4 years
STANDARD_DEVIATION 6.0 • n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
49.7 years
STANDARD_DEVIATION 5.1 • n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
48.3 years
STANDARD_DEVIATION 7.1 • n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Sex: Female, Male
AYA · Female
|
5 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
12 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
10 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
27 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Sex: Female, Male
AYA · Male
|
6 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
9 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
11 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
26 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Sex: Female, Male
Caregivers · Female
|
10 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
11 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
15 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
36 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Sex: Female, Male
Caregivers · Male
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
3 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
5 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
8 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
AYA · Hispanic or Latino
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
4 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
5 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
AYA · Not Hispanic or Latino
|
11 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
20 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
48 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
AYA · Unknown or Not Reported
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
3 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
3 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
10 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
14 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
41 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · American Indian or Alaska Native
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · Asian
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
2 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
2 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · Black or African American
|
1 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
4 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
3 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
8 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · White
|
10 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
15 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
17 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
42 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · More than one race
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
AYA · Unknown or Not Reported
|
0 Participants
n=11 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=21 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=53 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
1 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
1 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
3 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
5 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · White
|
9 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
12 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
15 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
36 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=10 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
0 Participants
n=14 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
2 Participants
n=20 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
2 Participants
n=44 Participants • Two rows were added ('AYA' and 'Caregivers') to reflect the different type of participants in the overall population. AYA and Caregiver units were randomized together, to the same arm, but completed baseline and post-intervention measures separately (i.e., AYA-report and Caregiver-report).
|
PRIMARY outcome
Timeframe: 8 weeks post-randomizationPopulation: NOTE. Measure was NOT administered to Usual Care group (per protocol). 13 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=1 Caregiver (in the DECIDES group) with missing data * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=22 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=35 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Acceptability of Decision Aid
AYA
|
4.10 Average Score on a Scale
Interval 1.0 to 5.0
|
4.06 Average Score on a Scale
Interval 1.0 to 5.0
|
—
|
|
Acceptability of Decision Aid
Caregivers
|
4.01 Average Score on a Scale
Interval 1.0 to 5.0
|
4.13 Average Score on a Scale
Interval 1.0 to 5.0
|
—
|
PRIMARY outcome
Timeframe: 8 weeks post-randomizationPopulation: NOTE. Measure was NOT administered to Usual Care group (per protocol). Measure was administered to Oncology Clinicians during Interview. 14 participants were excluded from analyses including: * n=8 (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group) * n=2 Oncology Clinicians with missing data
This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score \>80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and \<51 reflects letter grade "F" (adjective rating "awful").
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=35 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=11 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Usability of Decision Aid
AYA
|
75.96 Score on a scale
Standard Deviation 15.66
|
78.82 Score on a scale
Standard Deviation 13.90
|
—
|
|
Usability of Decision Aid
Caregivers
|
79.72 Score on a scale
Standard Deviation 12.77
|
83.33 Score on a scale
Standard Deviation 11.28
|
—
|
|
Usability of Decision Aid
Oncology Clinicians
|
—
|
—
|
86.98 Score on a scale
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Perceived Involvement in Shared Treatment Decision-Making Process
AYA
|
57.33 score on a scale
Standard Deviation 29.20
|
69.91 score on a scale
Standard Deviation 17.06
|
69.26 score on a scale
Standard Deviation 21.80
|
|
Perceived Involvement in Shared Treatment Decision-Making Process
Caregivers
|
69.63 score on a scale
Standard Deviation 24.06
|
77.78 score on a scale
Standard Deviation 15.07
|
73.06 score on a scale
Standard Deviation 20.83
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Perceptions of Physician Engagement in Decision-Making Process
AYA
|
73.00 Score on a scale
Standard Deviation 22.14
|
92.31 Score on a scale
Standard Deviation 14.23
|
82.78 Score on a scale
Standard Deviation 27.18
|
|
Perceptions of Physician Engagement in Decision-Making Process
Caregivers
|
76.67 Score on a scale
Standard Deviation 32.79
|
96.00 Score on a scale
Standard Deviation 9.66
|
95.00 Score on a scale
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: 8-weeks post randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a 25-item true/false questionnaire used to assess participant understanding of clinical trials and informed consent processes. Items are scored based on % correct, with higher scores reflecting more knowledge.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Knowledge of Cancer Clinical Trials
Caregivers
|
87.56 Percent Correct
Standard Deviation 5.46
|
88.00 Percent Correct
Standard Deviation 7.21
|
88.31 Percent Correct
Standard Deviation 10.39
|
|
Knowledge of Cancer Clinical Trials
AYA
|
87.60 Percent Correct
Standard Deviation 5.48
|
81.85 Percent Correct
Standard Deviation 10.91
|
80.47 Percent Correct
Standard Deviation 14.62
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Continuous scores were calculated from PRPQ items reflecting 'Perceived Benefits' (with a higher score suggesting positive attitudes) and from PRPQ items reflecting 'Perceived Barriers' (with a higher score suggesting negative attitudes). A 'Decision Balance' score was computed by converting the 'Perceived Benefits' and 'Perceived Barriers' scores to Z-scores, and then subtracting the 'Perceived Barriers Z-scores' from the 'Perceived Benefits Z-scores'. A 'Decision Balance' Z-score of 0 represents the population mean; a positive valence (3) reflects more positive attitudes to clinical trials and negative valence (-3) reflects more negative attitudes.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Attitudes Toward Cancer Clinical Trials
AYA: Decision Balance
|
0.20 Z-Score
Standard Deviation 1.35
|
-0.15 Z-Score
Standard Deviation 1.49
|
0.05 Z-Score
Standard Deviation 0.91
|
|
Attitudes Toward Cancer Clinical Trials
Caregivers: Decision Balance
|
0.03 Z-Score
Standard Deviation 1.69
|
0.05 Z-Score
Standard Deviation 1.87
|
0.33 Z-Score
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Uncertainty in Cancer Treatment Decision-Making Process
AYA
|
25.63 Score on a scale
Standard Deviation 12.68
|
23.44 Score on a scale
Standard Deviation 16.08
|
24.18 Score on a scale
Standard Deviation 20.36
|
|
Uncertainty in Cancer Treatment Decision-Making Process
Caregivers
|
25.00 Score on a scale
Standard Deviation 19.53
|
13.13 Score on a scale
Standard Deviation 12.93
|
20.02 Score on a scale
Standard Deviation 15.06
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret).
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Regret About Cancer Treatment Decision-Making Process
AYA
|
40.50 Score on a scale
Standard Deviation 32.87
|
27.31 Score on a scale
Standard Deviation 28.62
|
23.95 Score on a scale
Standard Deviation 24.24
|
|
Regret About Cancer Treatment Decision-Making Process
Caregivers
|
17.78 Score on a scale
Standard Deviation 18.22
|
28.00 Score on a scale
Standard Deviation 35.76
|
13.13 Score on a scale
Standard Deviation 24.14
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction.
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Satisfaction With Cancer Treatment Decision-Making Process
AYA
|
24.20 Score on a scale
Standard Deviation 3.49
|
25.23 Score on a scale
Standard Deviation 4.36
|
25.53 Score on a scale
Standard Deviation 4.45
|
|
Satisfaction With Cancer Treatment Decision-Making Process
Caregivers
|
24.89 Score on a scale
Standard Deviation 3.41
|
27.30 Score on a scale
Standard Deviation 3.23
|
26.44 Score on a scale
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: 8 weeks post-randomizationPopulation: 12 participants were excluded from analyses including: * n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention * n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach * n=2 Second Caregivers (in the DECIDES+ group)
This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident).
Outcome measures
| Measure |
DECIDES With Informational Handout (DECIDES)
n=19 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
|
DECIDES With Coach-Assisted Support (DECIDES+)
n=23 Participants
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
|
No Arm/Group
n=35 Participants
Oncology clinicians were not allocated to an intervention arm. They completed the Systems Usability Scale during a qualitative interview.
|
|---|---|---|---|
|
Self-confidence in Cancer Treatment Decision-Making Abilities
AYA
|
80.00 Score on a scale
Standard Deviation 14.60
|
78.15 Score on a scale
Standard Deviation 15.51
|
80.86 Score on a scale
Standard Deviation 16.02
|
|
Self-confidence in Cancer Treatment Decision-Making Abilities
Caregivers
|
81.06 Score on a scale
Standard Deviation 15.29
|
94.77 Score on a scale
Standard Deviation 8.09
|
86.93 Score on a scale
Standard Deviation 11.95
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DECIDES With Informational Handout (DECIDES)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DECIDES With Coach-Assisted Support (DECIDES+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oncology Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place