NCT01984671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

October 28, 2025

Completed
Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

October 31, 2013

Results QC Date

June 20, 2024

Last Update Submit

October 14, 2025

Conditions

Stem Cell Transplant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Cohen's D Effect Size of the Change in Pain Disability From Baseline to 10 Weeks

    Baseline to 10 weeks

  • Cohen's D Effect Size of the Change in Pain Self-efficacy From Baseline to 10 Weeks

    Baseline to 10 weeks

  • Cohen's D Effect Size of the Change in Fatigue From Baseline to 10 Weeks

    Baseline to 10 weeks

  • Cohen's D Effect Size of the Change in 2-minute Walk Test From Baseline to 10 Weeks

    Baseline to 10 weeks

Study Arms (2)

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.

Behavioral: Mobile Pain Coping Skills Training

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.

Interventions

Mobile Pain Coping Skills TrainingBEHAVIORAL
Mobile pain coping skills training (mPCST)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • receipt of an stem cell transplant due to an oncological disease,
  • no prior stem cell transplant,
  • report a clinical pain score of at least 3/10, and
  • an age of \> 21.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

  • 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.

    PMID: 29555620DERIVED

Results Point of Contact

Title
Tamara Somers, PhD
Organization
Duke University School of Medicine
tamara.somers@duke.edu
919-416-3408

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 15, 2013

Study Start

October 2, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 28, 2025

Results First Posted

October 28, 2025

Record last verified: 2025-10

Locations

US(1)