Trial Outcomes & Findings for Videos for Advance Care Planning in Young Adults (NCT NCT04149704)
NCT ID: NCT04149704
Last Updated: 2025-01-20
Results Overview
AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
baseline, 3 months
Results posted on
2025-01-20
Participant Flow
Patient recruited while in clinic; shift to almost all virtual recruitment in late 2020. Eligible individuals received a latter explaining the study and were called one week later to provide further details and determine interest.
All enrolled participant completed a baseline survey prior to randomization
Participant milestones
| Measure |
Standard Care - Patients
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
Standard Care - Caregivers
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
ACP Video Decision Aid - Patients
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
ACP Video Decision Aid - Caregivers
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
|---|---|---|---|---|
|
Baseline and Immediately Post
STARTED
|
26
|
25
|
25
|
26
|
|
Baseline and Immediately Post
COMPLETED
|
26
|
25
|
25
|
26
|
|
Baseline and Immediately Post
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Three Month Follow-up
STARTED
|
26
|
25
|
25
|
26
|
|
Three Month Follow-up
COMPLETED
|
21
|
21
|
20
|
20
|
|
Three Month Follow-up
NOT COMPLETED
|
5
|
4
|
5
|
6
|
Reasons for withdrawal
| Measure |
Standard Care - Patients
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
Standard Care - Caregivers
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
ACP Video Decision Aid - Patients
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
ACP Video Decision Aid - Caregivers
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
|---|---|---|---|---|
|
Three Month Follow-up
Death
|
2
|
0
|
0
|
0
|
|
Three Month Follow-up
Lost to Follow-up
|
1
|
4
|
5
|
5
|
|
Three Month Follow-up
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Three Month Follow-up
Not completed as dyad (one member of dayd did not complete initial timepoint so withdrawn from study
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Videos for Advance Care Planning in Young Adults
Baseline characteristics by cohort
| Measure |
Standard Care - Patient
n=26 Participants
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
Standard Care - Caregiver
n=26 Participants
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
ACP Video Decision Aid - Patient
n=24 Participants
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
ACP Video Decision Aid - Caregiver
n=24 Participants
The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.
* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care
* 10 minute video decision aid: describing the goals-of-care options .
* Follow telephone interview at 3 months
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
37.6 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
24 participants
n=5 Participants
|
24 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: Analyzed as dyad. If one individual of the dyad did not complete study procedures, those results were not analyzed. One AYA assigned to standard care did not have a caregiver that was able to participate. One AYA of a caregiver assigned to video decision aid was unable to participate. As the unit of measurement was the DYAD, these two individuals (one standard arm, one video) were not analyzed although they did complete enrollment and baseline and follow-up assessments (but not 3 month)
AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline
Outcome measures
| Measure |
ACP Video Decision Aid
n=25 Participants
* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire
* 10 minute video decision aid: describing the goals-of-care options
* Follow telephone interview at 3 months to assess goals of care
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
Standard Care
n=25 Participants
* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
|---|---|---|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care pre intervention · Number of dyads with concordant goals of care
|
20 Participants
|
15 Participants
|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care pre intervention · Number of dyads with disconcordant goals of care
|
5 Participants
|
10 Participants
|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care post intervention · Number of dyads with concordant goals of care
|
13 Participants
|
15 Participants
|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care post intervention · Number of dyads with disconcordant goals of care
|
12 Participants
|
10 Participants
|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care 3 months post intervention · Number of dyads with concordant goals of care
|
10 Participants
|
9 Participants
|
|
Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)
Concordance in goals of care 3 months post intervention · Number of dyads with disconcordant goals of care
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: AYA participants that had data at 3-month follow-up
Patients randomized to the video will have more ACP conversations and documentation after 3 months.
Outcome measures
| Measure |
ACP Video Decision Aid
n=23 Participants
* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire
* 10 minute video decision aid: describing the goals-of-care options
* Follow telephone interview at 3 months to assess goals of care
ACP video decision aid: 10 minute video decision aid describing the goals-of-care options
|
Standard Care
n=22 Participants
* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire
* Receive the verbal description of the three types of care
* Follow telephone interview at 3 months
Usual Care: Verbal description of the three types of care
|
|---|---|---|
|
Increased Advance Care Planning (ACP) Conversations
Change in number of AYAs that engaged in ACP conversations following the intervention to 3-months
|
13 Participants
|
13 Participants
|
|
Increased Advance Care Planning (ACP) Conversations
Change in number of AYAs that had ACP documentation from baseline to 3 months
|
2 Participants
|
4 Participants
|
Adverse Events
ACP Video Decision Aid - Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ACP Video Decision Aid - Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care - Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Standard Care - Caregiver
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