Trial Outcomes & Findings for mPCST for BMT Patients (NCT NCT01984671)
NCT ID: NCT01984671
Last Updated: 2025-10-28
Results Overview
Presented as the (total number of completed sessions for all participants) divided by the (total number of planned sessions for all participants) multiplied by 100. The goal of this study was to develop a PCST intervention that could be used to enhance the ability of HCT patients to manage their pain following transplant, that is feasible and acceptable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
10 weeks
Results posted on
2025-10-28
Participant Flow
Participant milestones
| Measure |
Mobile Pain Coping Skills Training (mPCST)
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mPCST for BMT Patients
Baseline characteristics by cohort
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
n=18 Participants
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
n=5 Participants
|
57.9 years
n=7 Participants
|
56.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Usual care participants did not attend sessions.
Presented as the (total number of completed sessions for all participants) divided by the (total number of planned sessions for all participants) multiplied by 100. The goal of this study was to develop a PCST intervention that could be used to enhance the ability of HCT patients to manage their pain following transplant, that is feasible and acceptable.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=108 mPCST sessions
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Feasibility as Measured by the Overall Percentage of Completed Sessions
|
83 percentage of sessions
|
—
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Usual care participants did not attend sessions.
The goal of this study was to develop a PCST intervention that could be used to enhance the ability of HCT patients to manage their pain following transplant, that is feasible and acceptable.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment
Helpful (reported in assessment)
|
80 percentage of participants
|
—
|
|
Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment
Easy to understand (reported in assessment)
|
100 percentage of participants
|
—
|
|
Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment
Acceptable (reported in assessment)
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksA positive value indicates improvement in pain disability and a negative value indicates a decline.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
n=18 Participants
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks
|
0.79 Cohen's d
|
0.69 Cohen's d
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksA positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
n=18 Participants
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks
|
0.61 Cohen's d
|
0.10 Cohen's d
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksA positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
n=18 Participants
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks
|
0.94 Cohen's d
|
0.81 Cohen's d
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksA positive value indicates improvement in the 2-minute walk test and a negative value indicates a decline.
Outcome measures
| Measure |
Mobile Pain Coping Skills Training (mPCST)
n=18 Participants
Participants in this condition completed the first session following their baseline survey assessment. The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient's medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. Last, participants completed the post-assessment.
|
Usual Care Control
n=18 Participants
Patients in this condition will have access to activity tracker syncing and daily symptoms assessment following their baseline survey assessment. HCT education participants will be encouraged to download the Transplant (HCT) Guidelines mobile app that is free of charge. Last, participants completed the post-assessment.
|
|---|---|---|
|
Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks
|
0.66 Cohen's d
|
0.41 Cohen's d
|
Adverse Events
Mobile Pain Coping Skills Training (mPCST)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control
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