Coping skills training for patients after stem cell transplant
Coping Skills Training for Symptom Management and Daily Steps (Step Up)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T, Car T |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06575712 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe cognitive impairments, brain metastases, or severe psychiatric conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Allison Diachina
- Email: allison.diachina@duke.edu
- Phone: 919-416-3421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.