NCT03960619|Completed
In Person and Mobile Health Coping Skills Training for Improving Symptom Management and Daily Steps in Hematopoietic Stem Cell Transplant Patients
CST Step Up
Loading search results
CST Step Up
Sponsor study identifier
interventional
8
1 country
1
Study Start
July 16, 2019
Actual (reported)Primary Completion
November 22, 2019
Actual (reported)Study Completion
November 22, 2019
Actual (reported)The purpose of the study is to assess the feasibility, acceptability, and efficacy of a novel mHealth behavioral intervention to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability. Our interdisciplinary team (psychiatry, hematology/oncology, occupational therapy) proposes a single arm pilot trial (N=20) to test a hybrid in-person and mHealth (video-conferencing, symptoms/activity monitoring, personalized feedback via text) HCT Coping Skills Training for Symptom Management and Daily Steps (CST Step-Up) intervention. CST Step-Up will provide patients with coping skills training and activity coaching sessions to enhance their ability to cope with symptoms that interfere with activity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2019
Actual (reported)May 23, 2019
Actual (reported)July 16, 2019
Actual (reported)November 22, 2019
Actual (reported)November 22, 2019
Actual (reported)Accrual as measured by number of participants recruited
Accrual will be indicated by meeting the recruitment goal
15 months
Adherence as measured by completing all intervention sessions
Adherence will be indicated by the proportion successfully completing intervention sessions
15 months
Attrition as measured by 80% participants completing the study.
Attrition will be indicated by 80% of consented participants completing the study protocol.
15 months
Acceptability as measured by 80% participants reporting satisfaction with CST program
Acceptability will be indicated by 80% of patients reporting satisfaction with CST Step-Up on the CSQ.
15 months
Change in Physical Disability
assessments at baseline (pre - treatment) and post-intervention at 3-months..
Change in Fatigue
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Change in Psychological Distress
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Change in Self-Efficacy for Symptom Management: PROMIS Self-Efficacy for Managing Symptoms Short Form
assessments at baseline (pre-treatment) and post-intervention at 3-months.
Symptom Monitoring
post-intervention at 3-months.
hybrid in-person and mHealth coping skills training and activity coaching intervention is to reduce physical disability and decrease pain, fatigue and stress while enhancing patients' abilities to cope with symptoms that interfere with activity.
We aim to test a combined coping skills training and activity coaching protocol that: first, is feasible and acceptable, and second, improves physical disability, as well as pain, fatigue, distress, and physical activity in HCT patients. We propose a novel intervention protocol that uses a hybrid in-person and mHealth intervention delivery model.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke university health system
Durham, North Carolina, 27707, United States
Tamara J Somers, PhD
Duke University
8 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
July 16, 2019
Actual (reported)Coping in African American Prostate Cancer Survivors
Contact the study team to confirm eligibility.
Primary Completion
November 22, 2019
Actual (reported)Study Completion
November 22, 2019
Actual (reported)Last Updated
June 13, 2023
Record last verified: 2023-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: