Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen after Allogenetic Hematopoietic Cell Transplantation

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ABSTRACT Allogeneic hematopoietic cell transplantation (HCT) can be a lifesaving treatment for patients with hematologic disease. It is also one of the most life-altering treatments, given the high risks of morbidity and mortality, and requiring extensive commitments of money, time, and effort. Following a protracted inpatient stay and initial successful engraftment of healthy cells, patients return to their homes where they must follow a complex medical regimen that requires the help of a family caregiver to reduce their risk of infection and other threats to long term treatment success. Adherence to the regimen by the patient and family caregiver, however, is a significant clinical problem. Evidence-based interventions to help patients and their family caregivers manage the many challenges of the post-HCT regimen together are urgently needed but have received little research attention. To address this need, we have developed a dyadic problem-solving therapy (DPST-HCT) intervention to help HCT patients and their family caregivers manage the post-HCT medical regimen as a team. The planned research will make use of a combination of qualitative and quantitative methods iteratively within a user-centered design approach to refine the intervention and provide evidence of acceptability, feasibility, and efficacy. In Stage 1, we will conduct focus groups and incorporate patient, family caregiver, and health care professional feedback on medical management challenges and the usefulness of the intervention. In Stage 2, we will interatively refine the intervention with a small number of patient-family caregiver dyads, resulting in a finalized intervention. In Stage 3, we will evaluate the final version of the DPST- HCT in a single-site randomized controlled trial to determine acceptability, feasibility, and efficacy. We will randomize 104 newly transplanted allogeneic HCT patient-family caregiver dyads (N=208) to the DPST-HCT arm or Enhanced Usual Care comparison arm and assess study outcomes at 1-, 5-, 12-, and 24-weeks post- intervention completion. We will (a) determine process considerations (acceptability, feasibility); (b) provide an initial test of intervention efficacy on primary outcomes (dyadic team-based management: adherence and self- efficacy), and secondary outcomes (patient and family caregiver well-being, perceived health, health-related quality of life, patient clinical events, and patient health care utilization. Anticipated results will provide further support for a dyadic team-based approach to post HCT medical regimen management and serve as the basis for a multi-site RCT to test DPST-HCT.