Background: There is increasing utility of novel agents in the treatment of Hodgkin lymphoma (HL) and the role of radiotherapy is evolving. Whilst there is a large body of research into the long-term outcomes of HL, this data is mostly related to conventional radiotherapy and chemotherapy regimens. With the advent novel therapies, our understanding of the long-term toxicities is also undergoing a period of dynamic change. Whilst recent trials provided abundant high-level short term follow up data, they fail to provide a full picture of the long-term morbidity and mortality associated with current therapy.
The My Hodgkin, My Health (MHMH) app will be the first designed to collect patient derived data from HL patients. The purpose of this study is to demonstrate feasibility of this novel construct by meeting pre-specified recruitment and retention targets. Given the good overall survival of HL, and the paucity of long-term data in an era of novel therapies, we feel this is the ideal space in which to develop this app to capture this data conveniently and economically.
Methods: This will be a pilot study to with Initial recruitment targeted at Australian participants of the RATHL study. This is a well-defined population who are familiar with study procedures and well connected with investigators who will disseminate recruitment information. To prove feasibility, the primary outcome of this study is to recruit ≥50% of Australian RATHL study participants and retain ≥ 50% of these participants at 12 months. Secondary endpoints will include disease status and relapse rates, fertility, and other long-term sequelae from HL treatment.
Screening and consent procedures will be done electronically. Subjects complete a baseline survey including details of their treatment and disease status as well as information about any treatment complications. Subjects will be encouraged to update their data and be prompted to save or update their data every 6 months through push notifications.
If the primary endpoint is met, the project will continue with a focus on the secondary endpoints. We also envisage collaboration with international investigators and global uptake of the app. Ideally MHMH will be an invaluable database for researchers moving forward and will facilitate clinical trials aimed at optimising treatment efficacy whilst balancing quality of life and treatment sequelae.
Gajan Kailainathan, Janlyn Falconer, Amy Baker, Nicole Wong Doo, Judith Trotman