Randomized trial protocol of bridge intervention for patients with serious mental illness and cancer.

153 Background: Individuals with serious mental illness (SMI) diagnosed with cancer often have disruptions in treatment, leading to premature mortality compared to patients without SMI. To address such gaps in care, we developed and piloted a collaborative care intervention for patients with SMI and cancer (Bridge). We now propose a randomized controlled trial (RCT) to investigate the impact of the Bridge intervention on disruptions in cancer care for patients with SMI. Methods: We will conduct a two-arm RCT (n = 120) comparing Bridge to enhanced usual care (EUC) for patients with SMI (schizophrenia, bipolar disorder, major depressive disorder) and newly diagnosed breast, lung, gastrointestinal, or head/neck cancer. The 12-week Bridge intervention includes: 1) assessment by a psychiatrist with expertise in oncology at cancer diagnosis, 2) involvement of a case manager to promote self-management and care coordination, 3) collaboration between psychiatry and oncology (e.g., joint visits, developing an integrated treatment plan) to address barriers to care, and 4) availability of study clinicians via phone, text, or in-person for consultation and follow-up with patients, caregivers, and oncology and community mental health clinicians. In the EUC arm, study staff will inform the treating oncologist of the psychiatric diagnosis and notify the patient and oncologist of available psychosocial services at enrollment. Patients will be randomized 1:1 to Bridge or EUC, stratified by presence of a caregiver. Identified caregivers will be co-enrolled, and patients without a caregiver will be eligible. We will utilize verbal consent, link study visits to oncology appointments, and personalize frequency and location (e.g., community, clinic, hospital) of contact with patients and caregivers to decrease burden and promote engagement. The primary outcome is the proportion of patients with disruptions in cancer care within 6 months of enrollment, confirmed by oncologists blinded to study arm. Secondary outcomes include clinician assessment of psychiatric illness severity as well as patient and caregiver reported measures (e.g., depression, engagement in care, treatment satisfaction). Results: N/A. Conclusions: N/A. Clinical trial information: NCT03360695.