Trial Outcomes & Findings for Building Resiliency Among Caregivers of Curvivors and Metavivors (NCT NCT05702723)
NCT ID: NCT05702723
Last Updated: 2026-04-13
Results Overview
Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
At Screening
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Smart-3RP
Survivors-caregivers will be randomized together (dyad), stratified by survivor status: curvivor (participants who have completed curative therapy) or metavivor (participants will metastatic disease), using a random plan generator with 1:1 randomization. Participants will complete study procedures as outlined:
* Baseline questionnaires.
* 9 virtual sessions of Smart-3RP.
* 3-month questionnaires.
* Optional collections of hair samples at enrollment and 6-month follow-up period to measure cortisol concentration.
* 6-month questionnaires.
* Optional exit interview with study staff.
|
Enhanced Usual Care
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
* Participants will be referred to a 14-week online support group.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline enrollment is presented separately for cancer survivors and caregivers
Baseline characteristics by cohort
| Measure |
Smart-3RP
n=48 Participants
Due to small sample size, this group represents all participants randomized to the SMART-3RP arm (including caregivers and survivors as individuals). The total number represents individuals rather than dyads.
|
Enhanced Usual Care
n=46 Participants
Due to small sample size, this group represents all participants randomized to the EUC arm (including caregivers and patients as individuals). The total number represents individuals rather than dyads.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Enrollment Total
Caregivers
|
24 Participants
n=24 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
23 Participants
n=23 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
47 Participants
n=47 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
|
Age, Continuous
Cancer survivor
|
62.9 Years
STANDARD_DEVIATION 11.3 • n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
61.4 Years
STANDARD_DEVIATION 13.6 • n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
62.2 Years
STANDARD_DEVIATION 12.4 • n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Age, Continuous
Caregiver
|
59.3 Years
STANDARD_DEVIATION 13.0 • n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
54.2 Years
STANDARD_DEVIATION 13.0 • n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
56.8 Years
STANDARD_DEVIATION 13.1 • n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Sex: Female, Male
Cancer Survivors · Female
|
10 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
12 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
22 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Sex: Female, Male
Cancer Survivors · Male
|
14 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
11 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
25 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Sex: Female, Male
Caregivers · Female
|
14 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
17 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
31 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Sex: Female, Male
Caregivers · Male
|
10 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
6 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
16 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · American Indian or Alaska Native
|
1 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · Asian
|
1 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
2 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
3 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · Black or African American
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · White
|
19 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
20 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
39 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · More than one race
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Cancer Survivors · Unknown or Not Reported
|
3 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
3 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · Asian
|
1 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
3 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
4 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · White
|
22 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
19 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
41 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
1 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
1 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Cancer survivors · Hispanic or Latino
|
2 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
5 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
7 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Cancer survivors · Not Hispanic or Latino
|
22 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
18 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
40 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Cancer survivors · Unknown or Not Reported
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
3 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
4 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
7 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
21 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
19 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
40 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=24 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=23 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
0 Participants
n=47 Participants • Baseline demographic variables are presented separately for cancer survivors and caregivers
|
|
Enrollment Total
Cancer Survivors
|
24 Participants
n=24 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
23 Participants
n=23 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
47 Participants
n=47 Participants • Baseline enrollment is presented separately for cancer survivors and caregivers
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Please note that data are reported here for individuals (including caregivers and survivors as individuals). A total of 976 participants (i.e., 488 caregiver+ survivor dyads) were eligible for the study.
Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver).
Outcome measures
| Measure |
All Participants
n=976 Participants
Here we include participants prior to randomization to either SMART-3RP or EUC (all enrolled in the study of those eligible to enroll)
|
Enhanced Usual Care
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
* Participants will be referred to a 14-week online support group.
|
|---|---|---|
|
Proportion of Enrolled Participants (Feasibility)
|
94 Participants
|
—
|
PRIMARY outcome
Timeframe: At 3 monthsPopulation: Please note that acceptability was only assessed for participants randomized to the SMART-3RP intervention (and not Enhanced Usual Care). We are considering data for the 37 individuals who had available data at program end (a subset of the 48 individuals randomized to receive SMART-3RP).
Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition.
Outcome measures
| Measure |
All Participants
n=37 Participants
Here we include participants prior to randomization to either SMART-3RP or EUC (all enrolled in the study of those eligible to enroll)
|
Enhanced Usual Care
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
* Participants will be referred to a 14-week online support group.
|
|---|---|---|
|
Proportion of Intervention Satisfaction (Acceptability)
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: At 3 monthsPopulation: Please note that the denominator for this feasibility index includes all individual participants who were consented.
Defined as the percent of participants (including survivors and caregivers as individuals) who complete the 3-month follow-up survey, with a feasibility cutoff defined as ≥ 70% of participants.
Outcome measures
| Measure |
All Participants
n=48 Participants
Here we include participants prior to randomization to either SMART-3RP or EUC (all enrolled in the study of those eligible to enroll)
|
Enhanced Usual Care
n=46 Participants
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
* Participants will be referred to a 14-week online support group.
|
|---|---|---|
|
Proportion of Study Retention (Feasibility)
|
39 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Please note that the denominator for this index of feasibility includes all individual participants who were randomized to the SMART-3RP intervention. This index is not applicable to participants who were randomized to EUC.
Defined as the percent of participants (including both survivors and caregivers as individuals) who attend at least 6 out of 9 SMART-3RP intervention sessions, with a feasibility cutoff of ≥ 70% of participants. This is relevant only to participants randomized to the SMART-3RP.
Outcome measures
| Measure |
All Participants
n=48 Participants
Here we include participants prior to randomization to either SMART-3RP or EUC (all enrolled in the study of those eligible to enroll)
|
Enhanced Usual Care
Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization.
* Participants will be referred to a 14-week online support group.
|
|---|---|---|
|
Proportion of Intervention Session Completion (Feasibility)
|
36 Participants
|
—
|
Adverse Events
Smart-3RP Survivors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Enhanced Usual Care Survivors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
SMART-3RP Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care Caregivers
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