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Completed

NCT Number: NCT01984671

mPCST for BMT Patients

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.

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Key information

Conditions

Stem Cell Transplant

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Mobile Pain Coping Skills Training

Behavioral

Primary outcomes

  1. Feasibility as Measured by the Overall Percentage of Completed Sessions

    Time frame: 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.

  2. Acceptability as Measured by the Percentage of Participants Who Responded in the Affirmative for Each Item on the Assessment

    Time frame: 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 outcomes

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

    Time frame: Baseline to 10 weeks

    A positive value indicates improvement in pain disability and a negative value indicates a decline.

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

    Time frame: Baseline to 10 weeks

    A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.

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

    Time frame: Baseline to 10 weeks

    A positive value indicates improvement in pain self-efficacy and a negative value indicates a decline.

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

    Time frame: Baseline to 10 weeks

    A positive value indicates improvement in the 2-minute walk test and a negative value indicates a decline.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2013
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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