# Randomized Controlled Trial of a Hybrid-Delivered Cognitive Behavioral Symptom Management and Activity Coaching Intervention for Stem Cell Transplant Patients

> **NIH NIH R01** · DUKE UNIVERSITY · 2024 · $561,734

## Abstract

Our objective is to use novel mobile health (mHealth) behavioral intervention approaches to enable patients
who have undergone hematopoietic stem cell transplant (HCT) to effectively cope with their symptoms to
improve their ability to engage in physical activity that can improve physical disability. In a NCI R21 study, we
developed a hybrid in-person and mHealth Coping Skills Training for Symptom Management and Daily Steps
(Step Up) intervention protocol, including mobile app. Step Up provides HCT patients with cognitive behavioral
coping skills training and occupational therapy (OT)-led activity coaching sessions to enhance their ability to
cope with symptoms – fatigue, pain, distress – that interfere with physical activity. Step Up has been developed
by experts in symptom management, members of the HCT medical team, and with extensive input from HCT
patients. Our R21 results show Step Up is feasible, acceptable to patients, and demonstrates a strong signal
for intervention benefits, including improvements in physical disability, symptoms, and activity (daily steps).
The next step in this research program is to use a randomized controlled trial (RCT) to test the efficacy of Step
Up compared to Usual Care Plus (UC+). Step Up includes one in-person symptoms coping skills session and
two activity coaching sessions during intensive outpatient care. Then, following discharge home, an additional
four integrated symptom coping and activity coaching sessions are delivered via videoconferencing. Step Up
includes a mobile app and activity trackers (Fitbits) to capture daily symptom, activity, and biometric data
allowing the study team to provide real-time personalized feedback. Our central hypothesis is Step Up will lead
to improvements in physical disability (primary outcome), as well as secondary outcomes of symptom severity,
physical activity, and digital biomarkers reflective of symptom burden following HCT. A RCT (N=177) will be
used to pursue three specific aims: 1) Test the efficacy of Step Up for improving physical disability, as well as
symptom severity, physical activity, and self-efficacy for symptom management compared to UC+; 2) Examine
the relationship between symptoms and activity; and 3) Test the efficacy of Step Up for improving digital
biomarkers reflective of symptom burden (heart rate, activity, sleep time) measured via Fitbits. The proposed
work is innovative and impactful for HCT patients as it addresses interfering symptoms, integrates evidence-
based coping skills training with OT sessions to increase activity while decreasing symptoms that interfere with
activity, and uses mHealth technology for personalized real-time feedback to patients. Positive results would
provide the first demonstration of efficacy of a hybrid-delivered cognitive behavioral coping skills training and
activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing
symptom burden and increasing activity. The pro...

## Key facts

- **NIH application ID:** 10937615
- **Project number:** 1R01CA291888-01
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Sarah Kelleher
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $561,734
- **Award type:** 1
- **Project period:** 2024-09-01 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10937615

## Citation

> US National Institutes of Health, RePORTER application 10937615, Randomized Controlled Trial of a Hybrid-Delivered Cognitive Behavioral Symptom Management and Activity Coaching Intervention for Stem Cell Transplant Patients (1R01CA291888-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10937615. Licensed CC0.

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