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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile pain coping skills training (mPCST) | Experimental | 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 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Pain Coping Skills Training | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 10 weeks |
| Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29555620 | Derived | Somers TJ, Kelleher SA, Dorfman CS, Shelby RA, Fisher HM, Rowe Nichols K, Sullivan KM, Chao NJ, Samsa GP, Abernethy AP, Keefe FJ. An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Mar 19;6(3):e66. doi: 10.2196/mhealth.8565. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Usual care participants did not attend sessions. | Posted | Number | percentage of sessions | 10 weeks | mPCST sessions | mPCST sessions |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Somers, PhD | Duke University School of Medicine | 919-416-3408 | tamara.somers@duke.edu |
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A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline. |
| 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. | 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. | Baseline to 10 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | Posted | Number | Cohen's d | Baseline to 10 weeks |
|
|
|
| Primary | 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. | Usual care participants did not attend sessions. | Posted | Number | percentage of participants | 10 weeks |
|
|
|
| Secondary | 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. | Posted | Number | Cohen's d | Baseline to 10 weeks |
|
|
|
| Secondary | 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. | Posted | Number | Cohen's d | Baseline to 10 weeks |
|
|
|
| Secondary | 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. | Posted | Number | Cohen's d | Baseline to 10 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Measurements |
|---|---|
|