Coping Skills Training for Symptom Management and Daily Steps (Step Up)

Recruiting now · Not applicable

Conditions studied: Hematopoietic Stem Cell Transplant, CAR-T Cell Therapy

In brief

The aim of this study is to test the efficacy of a hybrid in-person and mHealth coping skills training and activity coaching intervention (Step Up), to enable HCT patients to effectively cope with symptoms (pain, fatigue, and stress) to improve their ability to engage in physical activity that can improve physical disability.

Key facts

Study ID

NCT06575712

Run by

Duke University

People needed

177

Starts

2025-04-21

Expected to finish

2028-08-31

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Duke Cancer Institute — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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