Trial Outcomes & Findings for Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing HSCT (NCT NCT05216978)
NCT ID: NCT05216978
Last Updated: 2024-07-01
Results Overview
Feasibility of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone hematopoietic stem cell transplant (HSCT) using a single-arm trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
9 weeks
Results posted on
2024-07-01
Participant Flow
Although the study was divided into two phases under a single open-arm study, participants in both phases received the same study procedures so data reported represents patients in both two phases. Considering this is an open-pilot study, we recruited continuously for the study without distinguishing phases. All participants received the positive psychology intervention.
Participant milestones
| Measure |
PATH Intervention
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
PATH Intervention
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing HSCT
Baseline characteristics by cohort
| Measure |
PATH Intervention
n=15 Participants
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
|
|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Relationship Status
Married/living together
|
12 Participants
n=5 Participants
|
|
Relationship Status
Single
|
1 Participants
n=5 Participants
|
|
Relationship Status
Separated/divorced
|
1 Participants
n=5 Participants
|
|
Relationship Status
Missing
|
1 Participants
n=5 Participants
|
|
Religion
Agnostic
|
3 Participants
n=5 Participants
|
|
Religion
Catholic Christian
|
6 Participants
n=5 Participants
|
|
Religion
Other Christian
|
3 Participants
n=5 Participants
|
|
Religion
Jewish
|
1 Participants
n=5 Participants
|
|
Religion
None
|
1 Participants
n=5 Participants
|
|
Religion
Missing
|
1 Participants
n=5 Participants
|
|
Education
High school diploma
|
2 Participants
n=5 Participants
|
|
Education
Some college
|
2 Participants
n=5 Participants
|
|
Education
College degree
|
6 Participants
n=5 Participants
|
|
Education
Some postgraduate/professional education
|
2 Participants
n=5 Participants
|
|
Education
Postgraduate/professional degree
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: The analysis populations are as follows. Feasibility: Enrollment - 49 eligible participants were approached and 23 participants were enrolled. Of the 23 participants who enrolled. 8 participants did not start PATH: 3 withdrew from the study and 5 were lost to follow-up. For the feasibility analysis, the analysis population denominator is 15 participants who started PATH.
Feasibility of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone hematopoietic stem cell transplant (HSCT) using a single-arm trial.
Outcome measures
| Measure |
PATH Intervention
n=15 Participants
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
|
|---|---|
|
Feasibility of the PATH Intervention
Number of participants who completed at least 6/9 intervention sessions
|
15 participants
|
|
Feasibility of the PATH Intervention
Number of participants who completed all 9/9 intervention sessions
|
13 participants
|
|
Feasibility of the PATH Intervention
Number of participants who completed baseline and follow-up assessment battery
|
15 participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: For the acceptability analysis, the analysis population denominator was 15 participants who received PATH.
At the end of each weekly intervention session, acceptability was measured with ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated.
Outcome measures
| Measure |
PATH Intervention
n=15 Participants
Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.
Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
|
|---|---|
|
Acceptability Rate
Acceptability - Mean Ease Score
|
8.1 score on a 10.0-point scale
Interval 7.4 to 8.7
|
|
Acceptability Rate
Acceptability - Mean Utility Score
|
8.3 score on a 10.0-point scale
Interval 7.8 to 8.9
|
Adverse Events
PATH Intervention
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
Dr. Hermioni Amonoo, Director of Well-Being and Cancer Research Program
Brigham and Women's Hospital
Phone: 617-525-7472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place