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NCT06575712
Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Conditions: Hematopoietic Stem Cell Transplant, CAR-T Cell Therapy
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 177
Sponsor: Duke University
Location: Duke Cancer Institute Durham North Carolina
Summary
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT06575712). StuddyBuddy aggregates publicly available trial information.