Coping skills training for patients after stem cell transplant
Official title: Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Run by Duke University · NCT06575712 · Data updated 2026-11-12
This study is testing a new coping skills program to see if it helps people who have had a stem cell transplant manage pain, fatigue, and stress better than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 177 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T, Car T |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | April 21, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT06575712 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 who have received an autologous hematopoietic stem cell transplant and report significant fatigue, pain, and psychological distress.
✕Probably not a fit
Patients with severe cognitive impairments, brain metastases, or severe psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a hybrid intervention combining in-person and mobile health coping skills training, aimed at helping patients who have undergone hematopoietic stem cell transplant (HCT) manage symptoms such as pain, fatigue, and stress. The intervention, known as Step Up, seeks to enhance patients' ability to engage in physical activities that can alleviate physical disabilities. Participants will receive either the Step Up intervention or usual care plus additional support. The study focuses on improving the quality of life for HCT patients through targeted symptom management.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and physical functioning for patients recovering from hematopoietic stem cell transplant.
How similar studies have gone: Other studies have shown promise in using coping skills training and activity coaching for symptom management in similar patient populations, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * receipt of an autologous (auto) HCT or CAR-T cell therapy due to a hematologic malignancy, such as a diagnosis of leukemia, lymphoma, multiple myeloma * age \>18 * self-reported fatigue, pain, and psychological distress (confirmed at recruitment) - minimum two of three symptoms reported at \>3 on 0-10 scale * life expectancy \> 12 months Exclusion Criteria: * cognitive impairment (e.g., dementia) recorded in the chart or suspected by provider * metastases to the brain * presence of a severe psychiatric condition (e.g., psychotic disorder) that would contraindicate safe participation as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff * inability to converse in English
Where it's running
-
Duke Cancer Institute
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Allison Diachina
- Email: allison.diachina@duke.edu
- Phone: 919-416-3421
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.