Implementation and Effectiveness Trial of HN-STAR

In this cluster randomized hybrid implementation-effectiveness controlled trial, 10-18 intervention practices will provide care with access to HN-STAR, and 10-18 practices will provide usual care without access to HN-STAR. We will implement no more than five intervention sites within the first 3 months of activation. Providers at each site will be invited to view a video regarding head and neck survivorship care. Designated providers at each intervention site will be trained to use HN-STAR during routine follow-up care with survivors. Eligible survivors who completed treatment for head and neck cancer ≤24 months ago with no evidence of disease (N=298-400) will complete a Survivor Baseline Health Assessment prior to visiting an oncology provider, a brief Survivor Post-Visit Survey about their clinic visit, and a Survivor Follow-Up Health Assessment one year later. Survivors in the intervention arm will additionally complete Survivor Quarterly Health Assessments every three months after the clinic visit, which will produce an updated SCP. We will compare changes in patient-centered outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from health assessments. The primary patient-centered outcome is head and neck cancer-specific quality of life measured at baseline and follow-up. Other patient-centered outcomes include symptom burden, patient activation, and perceived quality of care, also measured at baseline and follow-up. The secondary outcome of receipt of guideline-concordant care will be assessed using data from the Survivor and Designated Clinician Post-Visit Surveys and the Primary Care Provider (PCP) and Oncology Medical Records Abstraction forms from oncology practices and primary care providers identified by enrolled survivors. NCORP staff at each practice will request outside records (with survivor permission via a signed local Medical Release Form) and abstract data from these medical records. Implementation data will come from Survivor Post-Visit Survey and Survivor Follow-up Health Assessment, interviews at two time points with a subset of survivors (Survivor Post-Visit and Follow-Up Interviews, N=40), interviews with a subset of primary care providers a year after the designated clinic visit (Primary Care Provider Interview, N=30-40), surveys of stakeholders and designated clinicians at two time points (Stakeholder and Designated Clinician Initial and Final Surveys), and interviews of stakeholders and designated clinicians at one time point (Stakeholder and Designated Clinician Final Interview). All interviews will be conducted by Memorial Sloan Kettering study team members.