An interventional study of Mobile Pain Coping Skills Training in Stem Cell Transplant, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
We used a small randomized controlled trial (n=36) to compare a Mobile Health Pain Coping Skills (mPCST) to Usual Treatment for patients having received hematopoietic stem cell transplant.
The investigator proposes to develop and test a Mobile Health Pain Coping Skills (mPCST) protocol for HSCT patients with persistent pain to meet the challenges of HSCT patients with pain as they transition from hospital based care to their home environment. We used a small randomized controlled trial to examine the feasibility and acceptability, and engagement in the developed mPCST protocol. We compared the effects of usual care to the developed mPCST protocol on pain disability, pain self-efficacy, fatigue, and physical disability.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
Behavioral: Mobile Pain Coping Skills Training
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
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.
Time frame: 10 weeks
Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment
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.
Time frame: 10 weeks
Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks
A positive value indicates improvement in pain disability and a negative value indicates a decline.
Time frame: Baseline to 10 weeks
Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks
A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
Time frame: Baseline to 10 weeks
Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks
A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
Time frame: Baseline to 10 weeks
Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks
A positive value indicates improvement in the 2-minute walk test and a negative value indicates a decline.
Time frame: Baseline to 10 weeks
| Milestone | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Started | 18 | 18 |
| Completed | 16 | 17 |
| Not completed | 2 | 1 |
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.
| percentage of sessions | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Feasibility as Measured by the Overall Percentage of Completed Sessions | 83 | — |
A positive value indicates improvement in pain disability and a negative value indicates a decline.
| Cohen's d | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks | 0.79 | 0.69 |
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.
| percentage of participants | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Helpful (reported in assessment) | 80 | — |
| Easy to understand (reported in assessment) | 100 | — |
| Acceptable (reported in assessment) | 100 | — |
A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
| Cohen's d | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks | 0.61 | 0.10 |
A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.
| Cohen's d | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks | 0.94 | 0.81 |
A positive value indicates improvement in the 2-minute walk test and a negative value indicates a decline.
| Cohen's d | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|
| Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks | 0.66 | 0.41 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Usual Care Control | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 13 | 26 |
| >=65 years | 5 | 5 | 10 |
| Age, Continuous(years) | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control | Total |
|---|---|---|---|
| Mean | 54.6 (29 to 70) | 57.9 (40 to 75) | 56.25 (29 to 75) |
| Sex: Female, Male(Participants) | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control | Total |
|---|---|---|---|
| Female | 11 | 7 | 18 |
| Male | 7 | 11 | 18 |
| Region of Enrollment(Participants) | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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