mPCST for BMT Patients

NCT ID: NCT01984671

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-02
• Study Completion Date: 2015-12-01

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.

Conditions

Stem Cell Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile Pain Coping Skills Training

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile Pain Coping Skills Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29555620 (View on PubMed)

Other Identifiers

Pro00047952

Identifier Type: -

Identifier Source: org_study_id