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Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06575712

Step Up Hybrid In-Person and Mobile Health Program for Adults Post Stem Cell or CAR-T Therapy to Manage Symptoms and Boost Physical Activity

Led by Duke University · Updated on 2026-07-15

177

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a hybrid in-person and mobile health coping skills training and activity coaching program called Step Up. This intervention is designed for adults who have undergone hematopoietic stem cell transplant HCT or CAR-T cell therapy for blood cancers like leukemia, lymphoma, or multiple myeloma. The goal is to help these patients manage symptoms such as pain, fatigue, and stress to improve their physical activity and reduce physical disability. Step Up includes seven sessions over 7 to 14 weeks, with three sessions delivered in person at the hospital or outpatient clinic and four sessions via videoconference after discharge. The intervention combines cognitive behavioral coping skills training and occupational therapy-led activity coaching. Participants use a mobile app and Garmin activity trackers to monitor daily symptoms, activity, and biometric data, which allows personalized real-time feedback. A control group receives usual medical care plus seven educational videos delivered weekly via the study app. Participants complete assessments at baseline, post-intervention 2-3 months after baseline, and at 3- and 6-month follow-ups. These assessments measure physical disability through walking tests and questionnaires, symptom severity, daily step counts, psychological distress, and self-efficacy for symptom management. The study aims to track changes in physical function and symptoms over time while monitoring safety and adherence through digital tools. The total study duration extends until August 2028.

CONDITIONS

Brief Title

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

Research Team

A

Allison Diachina

S

Sarah Kelleher, PhD

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