# Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients

> **NIH NIH R21** · DUKE UNIVERSITY · 2020 · $210,105

## Abstract

The objective of this study is to develop and test a novel mobile health (mHealth) behavioral intervention to
enable Hematopoietic stem cell transplant (HCT) patients to cope with their symptoms to improve their ability
to engage in physical activity that can improve physical disability. We developed a mHealth pain coping skills
training program for HCT patients and found in a small trial (NCI R21) that better pain management provided
some advantages for physical disability and activity. The next step in this research is to enhance our current
coping skills program to address pain, fatigue, and psychological distress, and their interference with daily
activity. Using the NIH Treatment Development Stage Model as a guide (Stage I), our interdisciplinary team will
develop a hybrid in-person and mHealth HCT Coping Skills Training for Symptom Management and Daily
Steps (CST Step-Up) intervention protocol. CST Step-Up will provide patients with cognitive behavioral coping
skills training and activity coaching sessions to enhance their ability to cope with symptoms (pain, fatigue,
distress) that interfere with physical activity. CST Step-Up will be developed by experts in symptom
management, members of the HCT medical team, and with extensive input from HCT patients. Innovative
features to be considered in CST Step-Up development include: in-person sessions prior to discharge with
subsequent sessions occurring at home via video-conferencing; a study mobile application and wireless
activity trackers to capture and transmit symptom and activity data to the study team in real-time with
subsequent personalized feedback via push notification; cognitive behavioral strategies to decrease the impact
of symptoms – pain, fatigue, distress – that most interfere with physical activity. Our central hypothesis is that
this process will develop a CST Step-Up protocol that is feasible and acceptable and leads to reduced physical
disability, as well as decreased symptom burden and increased physical activity. We will pursue three specific
aims: 1) Fully develop the CST Step-Up protocol for HCT patients. Development will consist of 5 focus groups
with HCT patients (n=6/group), a focus group with HCT providers (N=6), and user testing with 10 HCT patients.
2) Use a small randomized controlled trial (N=40) to examine feasibility and acceptability of the developed CST
Step-Up protocol. Feasibility will be assessed via (a) study accrual, (b) protocol adherence, and (c) retention.
3) Examine outcome patterns suggesting the efficacy of the CST Step-Up protocol for improving physical
disability and other outcomes compared to an HCT Education group. Confirmed hypotheses would provide the
first demonstration of the feasibility, acceptability, and positive impact of a hybrid in-person and mHealth
coping skills training and activity coaching intervention that reduces physical disability by concurrently and
synergistically decreasing symptom burden and increasing physical activity. T...

## Key facts

- **NIH application ID:** 9840464
- **Project number:** 5R21CA235083-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Sarah Kelleher
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $210,105
- **Award type:** 5
- **Project period:** 2019-01-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9840464

## Citation

> US National Institutes of Health, RePORTER application 9840464, Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients (5R21CA235083-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9840464. Licensed CC0.

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