Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorDuke University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Step Up
- Usual Care Plus (UC+)
Treatment groups
177 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov