PROJECT SUMMARY
Many efficacious family-based interventions (FBIs) exist in cancer, but few have been integrated in routine care
because they have not been designed/reported in a way that supports implementation. Barriers include resource-
intensive designs that are incompatible with clinical workflows (e.g., multiple in-person visits or phone sessions
with healthcare service providers) and a lack of healthcare reimbursement for services provided to caregivers.
Making delivery channel adaptations could facilitate clinical uptake, and improve outcomes, but little guidance
for adapting in-person/telephone-based FBIs for delivery via web/mobile platforms exists. This study uses
Implementation Science (IS) and human-computer interaction principles to develop a model for adapting FBIs
for digital delivery with the goal of improving uptake in oncology clinical care settings. We will adapt a highly
promising telephone-based FBI called SHARE (Spouses coping with the Head and neck Radiation Experience)
for delivery via mobile web (AIM 1), evaluate the feasibility, acceptability and non-inferiority of the new SHARE
2.0 prototype (AIM 2A), and elucidate factors that may influence implementation of SHARE 2.0 (AIM 2B). For
AIM 1, we will adapt SHARE through collaborative efforts by assembling a stakeholder advisory committee (SAC)
of 6 HNC patients and 6 caregivers to provide feedback on unadapted SHARE materials and desired technical
features of SHARE 2.0 to inform an adaptation blueprint. Next, we will apply the Accelerated Creation-to-
Sustainment (ACTS) model to iteratively develop SHARE 2.0 followed by usability testing with 5 patients and 5
caregivers. The outcome will be a functional prototype that is free from significant usability errors. For AIM 2A,
we will conduct a single-arm trial of SHARE 2.0 with 65 patient-caregiver dyads. Participants complete surveys
before initiating external beam radiation therapy (EBRT) and 1 month post-EBRT. We will judge the trial feasible
and acceptable if results are consistent with at least 70% of eligible patients/caregivers enrolling and at least
80% reporting satisfaction with content/logistics. We will also examine whether SHARE 2.0 performs comparably
to SHARE by comparing findings from this trial to the results of the original SHARE pilot trial. For AIM 2B, we
will apply the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) QuEST (Qualitative
Evaluation for Systematic Translation) mixed-methods framework to identify individual/organizational factors that
may influence future adoption, implementation, and sustainability of SHARE 2.0 before proceeding to a hybrid
implementation-effectiveness trial. Overall, this study will yield a functioning technology-enabled intervention that
delivers symptom-management support, and meets the needs of stakeholders, thereby maximizing likelihood of
uptake and sustainability in oncology clinical care. If successful, it could serve as a model for adapting other
FBIs for digital delivery and improve palliative and supportive care delivery in cancer.