Actively Recruiting
Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Led by Duke University · Updated on 2026-04-09
177
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a hybrid in-person and mobile health (mHealth) coping skills training and activity coaching program called Step Up. This study focuses on patients 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 disability. Participants in the Step Up group will complete seven sessions over 7 to 14 weeks, including three in-person sessions at the hospital or clinic and four video sessions after discharge. These sessions include coping skills training and occupational therapy-led activity coaching. The study uses wearable activity trackers and a mobile app to monitor daily symptoms, activity, and biometric data, giving personalized real-time feedback. A comparison group receives usual medical care plus educational videos through an app but not the Step Up program. During the study, participants will undergo assessments at baseline, post-intervention (2-3 months), 3-month, and 6-month follow-ups. These include measures of physical disability using the Functional Assessment of Cancer Therapy and the Six-Minute Walk Test, as well as evaluations of fatigue, pain, psychological distress, daily step counts, and self-efficacy for symptom management. The study aims to understand how symptoms affect activity and to test the effect of the Step Up program on digital biomarkers like heart rate and sleep time. Participant involvement will last several months with ongoing monitoring and support.
CONDITIONS
Brief Title
Coping Skills Training for Symptom Management and Daily Steps (Step Up)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received an autologous hematopoietic stem cell transplant or CAR T cell therapy for a blood cancer such as leukemia, lymphoma, or multiple myeloma
- Age over 18 years
- Self-reported fatigue, pain, or psychological distress, with at least two symptoms rated above 3 on a 0-10 scale
- Life expectancy greater than 12 months
You will not qualify if you...
- Cognitive impairment such as dementia
- Brain metastases
- Severe psychiatric conditions that make safe participation impossible
- Inability to speak or understand English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 14 weeks
Participants in the Step Up group complete 7 sessions of coping skills training and activity coaching delivered both in-person and via videoconferencing over 7 to 14 weeks. Participants in the Usual Care Plus group receive educational videos via an app over the same period.
3 in-person sessions and 4 videoconference sessions for Step Up participants; educational videos accessed weekly for 7 weeks for Usual Care Plus participants
Duration - Up to 6 months after treatment
Participants complete assessments to measure changes in physical disability, symptoms, activity levels, and self-efficacy at multiple time points following the intervention.
Assessments at post-intervention (2-3 months), 3 months, and 6 months follow-up
Trial Site Locations
Total: 1 location
1
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
A
Allison Diachina
S
Sarah Kelleher, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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