mPCST for BMT Patients

Home-Based Tablet Computer Pain Coping Skills Following Stem Cell Transplant

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.

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplant
• Intervention / Treatment: Behavioral: Mobile Pain Coping Skills Training

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mobile Pain Coping Skills Training
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimated): November 15, 2013

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00047952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No