Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial).

BACKGROUND: Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~ 76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care. Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles and the Cancer Council Australia's Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities and psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL I intervention for implementing an integrated, shared care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma.
METHODS: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin's and non-Hodgkin's lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL I). GOSPEL I is a nurse-enabled, pre-specified shared care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient-reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference, and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed. DISCUSSION: This trial is designed to explore the feasibility and acceptability of a new model of shared care for lymphoma survivors. Patient-reported outcomes as well as potential barriers to implementation will be analyzed to inform a larger definitive clinical trial testing the effects and implementation of a shared care model on health-related quality of life of lymphoma survivors. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12620000594921 . Registered on 22 May 2020.

RCT Entities:   Population Interventions Outcomes