Stem Cell Transplant
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMobile Pain Coping Skills Training
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. receipt of an stem cell transplant due to an oncological disease, 2. no prior stem cell transplant, 3. report a clinical pain score of at least 3/10, and 4. an age of \> 21.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by the Overall Percentage of Completed Sessions | 10 weeks | 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. |
| Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks | Baseline to 10 weeks | A positive value indicates improvement in pain disability and a negative value indicates a decline. |
| Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks | Baseline to 10 weeks | A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline. |
| Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks | Baseline to 10 weeks | A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline. |
| Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks | Baseline to 10 weeks | A positive value indicates improvement in the 2-minute walk test and a negative value indicates a decline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Total | Mobile Pain Coping Skills Training (mPCST) | Usual Care Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 5 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 13 Participants | 13 Participants |
| Age, Continuous | 56.25 years | 54.6 years | 57.9 years |
| Region of Enrollment United States | 36 Participants | 18 Participants | 18 Participants |
| Sex: Female, Male Female | 18 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: 10 weeks
Population: Usual care participants did not attend sessions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | 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 |
| Mobile Pain Coping Skills Training (mPCST) | 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 |
| Mobile Pain Coping Skills Training (mPCST) | 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 |
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.
Time frame: 10 weeks
Population: Usual care participants did not attend sessions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | Feasibility as Measured by the Overall Percentage of Completed Sessions | 83 percentage of sessions |
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.
Time frame: Baseline to 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks | 0.66 Cohen's d |
| Usual Care Control | Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks | 0.41 Cohen's d |
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.
Time frame: Baseline to 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks | 0.94 Cohen's d |
| Usual Care Control | Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks | 0.81 Cohen's d |
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.
Time frame: Baseline to 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks | 0.79 Cohen's d |
| Usual Care Control | Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks | 0.69 Cohen's d |
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.
Time frame: Baseline to 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Pain Coping Skills Training (mPCST) | Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks | 0.61 Cohen's d |
| Usual Care Control | Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks | 0.10 Cohen's d |