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NCT03859765 · ClinicalTrials.gov registry record · NA
In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03859765 is a NA study that has completed, run by Duke University. The registered enrollment target is 40 participants.
The verdict
NCT03859765, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Hematopoietic stem cell transplant (HCT) is an aggressive treatment for life-threatening cancers. HCT improves survival, but most HCT patients experience significant physical disability, which is exacerbated by persistent symptoms. Pain, fatigue, and psychological distress are the most prevalent and debilitating symptoms. HCT patients experience a significant increase in disability as their pain, fatigue, and distress increase. This disability and symptom burden interferes with patients' ability to engage in recommended physical activity that can improve disability, symptoms, and other outcomes. Disability and symptoms also complicate an already challenging recovery course; HCT patients return home, often far from their medical team, are restricted from normal activities and socially isolated. These disability, symptom and activity challenges increase the risk for post-transplant complications and may compromise life expectancy. Teaching HCT patients to cope with symptoms and activity is critical to helping them increase activity and reduce disability. Cognitive behavioral coping skills training protocols can enhance HCT patients' ability to cope with symptoms (pain, fatigue, distress) that interfere with physical activity. However, the application of these protocols to HCT patients is limited by in person sessions, delivery of sessions in a medical center setting, and/or lack of tailoring to HCT patients' specific needs. Mobile health (mHealth) technologies can improve and extend intervention strategies to cope with symptoms and physical activity upon return home. Behavioral intervention strategies are needed to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability. The investigators aim to develop and 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, fat
Interventions
- BEHAVIORAL HCT Symptoms and Steps
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2021-12-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03859765
The ClinicalTrials.gov registry entry for NCT03859765 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HCT Symptoms and Steps is the first listed.
NCT03859765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03859765 about?
NCT03859765 is a clinical study titled "In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients". Hematopoietic stem cell transplant (HCT) is an aggressive treatment for life-threatening cancers. HCT improves survival, but most HCT patients experience significant physical disability, which is exacerbated by persistent symptoms. Pain, fatigue, and psychological distress are the most prevalent and...
What is the current status of trial NCT03859765?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-07-23. Estimated completion is 2021-12-20.
What interventions are being tested in trial NCT03859765?
The interventions under investigation include: HCT Symptoms and Steps (BEHAVIORAL).
Who is sponsoring clinical trial NCT03859765?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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