PROJECT SUMMARY Candidate. This K23 proposal will position Dr. Nelson to become an independent investigator with expertise in developing and testing evidence-based interventions to improve patient and treatment-related outcomes for patients with hematologic conditions. Dr. Nelson demonstrates promise as a clinical researcher (20 publications and over 50 presentations), and with additional training and mentorship will contribute to national and international efforts to reduce symptom burden and improve quality of life for patients with blood disorders. Mentorship. The mentor team is comprised of internationally recognized investigators in behavioral interventions, cancer care, and patient-reported outcomes (mentor: Joseph Greer, PhD), and transplant care and supportive care interventions (co-mentor: Areej El-Jawahri, MD). A scientific advisory committee with complementary expertise will provide guidance on: qualitative data methods (Lara Traeger, PhD); clinical assessment and management of fatigue (Heather Jim, PhD); and biostatistics (Dustin Rabideau, PhD). Training Plan. Dr. Nelson will achieve short-term goals through a coordinated research and training plan in (1) HCT medical issues, (2) intervention development and qualitative data methods, and (3) randomized clinical trial design, testing, and assessment. In addition to regular mentorship meetings and experiential training through the research plan, Dr. Nelson will complete advanced coursework and didactic trainings, attend and present at seminars and national conferences, and publish findings in peer-reviewed journals. Background. Hematopoietic stem cell transplant (HCT) is a potentially curative treatment for patients with life-threatening blood disorders; yet, as many as 64% of HCT recipients go on to experience profoundly debilitating fatigue up to six years post- transplant. Fatigue persists despite routine medical intervention, and empirically-tested interventions have been largely ineffective at managing post-transplant fatigue. Cognitive-behavioral therapy (CBT) is an evidence-based treatment for fatigue, with observed effect sizes for fatigue reduction that are often two to three times greater than exercise interventions among chronically ill patients. Despite the pressing need, CBT for fatigue reduction has not been investigated in the HCT setting. Research Strategy. To address this gap, the proposed study employs a two-stage design to develop and test a videoconference, cognitive-behavioral intervention (Vitalize- HCT) to reduce fatigue and improve quality of life among persistently fatigued HCT survivors at the Massachusetts General Hospital Cancer Center. Stage I includes (1) intervention development with input from the empirical literature, psychologists and oncology clinicians, and open-ended interviews with HCT recipients (n=20) and clinicians (n=5), and (2) a pilot study to refine the intervention and evaluate its acceptability (n=6). Stage II will entail conducting a randomized controlled trial (n=75) to assess the feasibility and preliminary efficacy of the Vitalize-HCT for improving patient-reported fatigue and QOL outcomes compared to minimally enhanced usual care. This K23 lays the groundwork for an R01 to assess efficacy in a full-scale trial.

PROJECT NARATIVE As many as two-thirds of hematopoietic stem cell transplant (HCT) recipients experience persistent, clinically significant fatigue up to six years following HCT despite routine medical management. Existing behavioral interventions often fail to meet the needs of a post-HCT population by solely including patients with malignant underlying disease, focusing on a single target (e.g., exercise), or intervening during the peri-transplant period without consideration for long-term HCT survivors’ needs. A videoconferencing-based cognitive-behavioral intervention that addresses population-specific multifactorial contributors to persistent post-HCT fatigue may reduce fatigue and improve quality of life for HCT survivors.