Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer

Contemp Clin Trials. 2022 Dec:123:106975. doi: 10.1016/j.cct.2022.106975. Epub 2022 Oct 25.

Abstract

Background: Individuals with serious mental illness (SMI) experience inequities in cancer care that contribute to increased cancer mortality. Involving mental health at the time of cancer diagnosis may improve cancer care delivery for patients with SMI yet access to care remains challenging. Collaborative care is a promising approach to integrate mental health and cancer care that has not yet been studied in this marginalized population.

Methods/design: We describe a 24-week, two-arm, single-site randomized trial of person-centered collaborative care (Bridge) for patients with SMI (schizophrenia, bipolar disorder, or major depression with psychiatric hospitalization) and their caregivers. 120 patients are randomized 1:1 to Bridge or Enhanced Usual Care (EUC) along with their caregivers. Researchers proactively identify individuals with SMI and a new breast, lung, gastrointestinal, or head and neck cancer that can be treated with curative intent. EUC includes informing oncologists about the patient's psychiatric diagnosis, notifying patients about available psychosocial services, and tracking patient and caregiver outcomes. Bridge includes a proactive assessment by psychiatry and social work, a person-centered, team approach including collaboration between mental health and oncology, and increased access to evidence-based psycho-oncology care. The primary outcome is cancer care disruptions evaluated by a blinded panel of oncologists. Secondary outcomes include patient and caregiver-reported outcomes and healthcare utilization. Barriers to Bridge implementation and dissemination are assessed using mixed methods.

Discussion: This trial will inform efforts to systematically identify individuals with SMI and cancer and generate the first experimental evidence for the impact of person-centered collaborative care on cancer care for this underserved population.

Trial registration: ClinicalTrials.gov NCT03360695.

Keywords: Collaborative care; Health equity; Mental illness; Psycho-oncology; Severe mental disorder.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Caregivers / psychology
  • Humans
  • Mental Disorders* / psychology
  • Neoplasms* / complications
  • Neoplasms* / therapy
  • Oncologists*
  • Randomized Controlled Trials as Topic
  • Self Care

Associated data

  • ClinicalTrials.gov/NCT03360695