Status:
RECRUITING
Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Hematopoietic Stem Cell Transplant
CAR-T Cell Therapy
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 sym...
Detailed Description
The objective of this R01 project is to use novel mobile health (mHealth) behavioral intervention approaches to enable patients who have undergone hematopoietic stem cell transplant (HCT) and Car T ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06575712
Start Date
April 21 2025
End Date
August 31 2028
Last Update
July 4 2025
Active Locations (1)
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1
Duke Cancer Institute
Durham, North Carolina, United States, 27705