Trial Outcomes & Findings for Improving Informed Consent for Palliative Chemotherapy (NCT NCT02282722)
NCT ID: NCT02282722
Last Updated: 2021-10-14
Results Overview
Patients were asked "How likely do you think that chemotherapy is to cure your cancer?" with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of "not at all likely" was considered accurate. All other responses, including don't know, were considered inaccurate.
COMPLETED
NA
216 participants
3 months
2021-10-14
Participant Flow
216 participants were consented to this study. Of these, 16 were were not eligible to be randomized and 14 did not complete a baseline assessment. After consultations with the study statistician, these participants were intentionally excluded from our analytic cohort. Therefore, 186 participants are included in the participant flow module.
Participant milestones
| Measure |
Patient Usual Care Arm
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
92
|
|
Overall Study
2-week Assessment
|
79
|
75
|
|
Overall Study
3-month Assessment
|
71
|
73
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Informed Consent for Palliative Chemotherapy
Baseline characteristics by cohort
| Measure |
Usual Informed Consent
n=94 Participants
Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.
Usual, standard-of-care informed consent for chemotherapy: The enrolling site's institutional standard-of-care informed consent materials.
|
Investigational Informed Consent
n=92 Participants
Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.
Investigational informed consent for chemotherapy: Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education
College degree or higher
|
49 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Education
Unknown/missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Continuous
|
59.2 Years
n=5 Participants
|
59.4 Years
n=7 Participants
|
59.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Live alone
Yes
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Live alone
No
|
76 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Live alone
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Grade school or less
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
High school graduate, or some college
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Diagnosis
Metastatic colorectal cancer
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Diagnosis
Advanced pancreatic cancer
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
31 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
ECOG Performance Status
1 - Restricted in physically strenuous activity
|
42 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
ECOG Performance Status
2 - Ambulatory but unable to work
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ECOG Performance Status
3 - Capable of limited self-care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
4 - Completely disabled
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
Unknown/Missing
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPatients were asked "How likely do you think that chemotherapy is to cure your cancer?" with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of "not at all likely" was considered accurate. All other responses, including don't know, were considered inaccurate.
Outcome measures
| Measure |
Patient Usual Care Arm
n=71 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=73 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Number of Patients With Accurate Understanding of Chemotherapy Benefits
Accurate
|
39 Participants
|
39 Participants
|
|
Number of Patients With Accurate Understanding of Chemotherapy Benefits
Inaccurate
|
30 Participants
|
31 Participants
|
|
Number of Patients With Accurate Understanding of Chemotherapy Benefits
Did not answer
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPatients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.
Outcome measures
| Measure |
Patient Usual Care Arm
n=79 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=75 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Number of Patients With Accurate Understanding of Chemotherapy Risks
Inaccurate
|
47 Participants
|
33 Participants
|
|
Number of Patients With Accurate Understanding of Chemotherapy Risks
Accurate
|
31 Participants
|
41 Participants
|
|
Number of Patients With Accurate Understanding of Chemotherapy Risks
Unknown/missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPatients were asked "according to your doctor, what is the goal of the chemotherapy?" with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; "to cure" was considered inaccurate.
Outcome measures
| Measure |
Patient Usual Care Arm
n=79 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=75 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Unknown/missing
|
1 Participants
|
1 Participants
|
|
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Inaccurate
|
10 Participants
|
9 Participants
|
|
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Accurate
|
68 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 2 weeksDecisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict
Outcome measures
| Measure |
Patient Usual Care Arm
n=79 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=75 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores
|
5.2 units on a scale
Standard Deviation 1.7
|
5.5 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 2 weeksAchievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).
Outcome measures
| Measure |
Patient Usual Care Arm
n=79 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=75 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
No
|
48 Participants
|
39 Participants
|
|
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
Yes
|
30 Participants
|
35 Participants
|
|
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
Unknown/missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeksSatisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged ("does not apply" excluded), creating a score of 1 to 4, with 4 being the most satisfied.
Outcome measures
| Measure |
Patient Usual Care Arm
n=79 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=75 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores
|
3.6 units on a scale
Standard Deviation 0.5
|
3.7 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Patient Usual Care Arm
n=71 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=73 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
No
|
60 Participants
|
55 Participants
|
|
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Yes
|
10 Participants
|
16 Participants
|
|
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Unknown/missing
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsDecisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.
Outcome measures
| Measure |
Patient Usual Care Arm
n=71 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=73 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale
|
79.6 units on a scale
Standard Deviation 19.3
|
84.7 units on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 3 monthsEmotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.
Outcome measures
| Measure |
Patient Usual Care Arm
n=71 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=73 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment
|
16.5 units on a scale
Standard Deviation 4.6
|
17.3 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 3 monthsPrognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (\<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, \>10 years). This measure was adapted from the CANCORS trial.
Outcome measures
| Measure |
Patient Usual Care Arm
n=71 Participants
Patients randomized to usual care informed consent materials.
|
Patient Investigational Care Arm
n=73 Participants
Patients randomized to the investigational informed consent materials.
|
|---|---|---|
|
Patient-Reported Prognostic Understanding in Median Years
|
2.5 years
Interval 1.5 to 4.0
|
2.5 years
Interval 1.5 to 4.0
|
Adverse Events
Patient Usual Care Arm
Patient Investigational Care Arm
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
Restriction type: GT60