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

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 evidencebased 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 proposed research has the potential to produce significant public health benefit by redesigning existing modes of behavioral intervention delivery, improving continuity and coordination of care, and ultimately enhancing patient outcomes.