Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients following hematopoietic stem cell transplant or CAR T-cell therapy: Protocol of a randomized controlled trial.

BackgroundPatients undergoing hematopoietic stem cell transplant (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy experience significant disability exacerbated by persistent fatigue, pain, and psychological distress. These symptoms limit physical activity, one of the most effective and recommended strategies for reducing disability. Cognitive behavioral interventions improve cancer-related symptoms but have not been adapted for this unique patient population.Methods/designThis randomized controlled trial will test Step Up, a hybrid-delivered (in-person and mobile health) intervention that integrates cognitive behavioral symptom management with occupational therapy (OT)-led activity coaching. Adults (N = 177) post-HCT or CAR-T who report ≥2 target symptoms (fatigue, pain, psychological distress) at moderate levels (≥3/10) will be randomized 1:1 to Step Up or Usual Care Plus. Step Up includes seven weekly sessions: three in-person during intensive outpatient care and four videoconferencing at home, supported by a mobile app with activity trackers and personalized feedback. Usual Care Plus provides seven educational videos and activity monitoring. The primary outcome is physical disability assessed post-intervention (10-14 weeks after baseline). Secondary outcomes include fatigue, pain, psychological distress, daily steps, self-efficacy for symptom management, and digital symptom biomarkers (e.g., sleep). Assessments occur at baseline, post-intervention, and 3- and 6-month follow-ups.ConclusionThis is the first trial to test a hybrid-delivered, theory-based intervention integrating symptom management and OT-led activity coaching for HCT and CAR-T patients. Step Up may reduce physical disability and improve clinical outcomes. If successful, it could lead to widespread implementation to improve recovery during the critical transition from intensive outpatient care to home.