Improving Care Delivery for Individuals With Mental Illness and Cancer Across a Cancer Center Network: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 248
- Primary Endpoint
- Cancer Care Disruption
Study Overview
Brief Summary
The proposed project is an implementation-effectiveness randomized trial of a person-centered collaborative care model for patients with serious mental illness and new cancer. The BRIDGE NET intervention is theoretically informed, pragmatic, and delivered virtually by an interdisciplinary team and includes early psychiatry consultation, integrated oncology and mental health treatment planning and regular patient outreach to adddress barriers to care. The BRIDGE NET intervention addresses the unique needs of patients with mental illness and cancer. To increase the reach of specialty cancer and mental health care, there is a critical need for interventions that can be delivered virtually. This work has can inform the standard of care for patients with serious mental illness and cancer and lay the groundwork for future multi--site trials.
Detailed Description
This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE NET intervention. The proposed project addresses multiple modifiable disparities in cancer treatment and outcomes for a marginalized population of adults with SMI, who experience inequities in cancer treatment. The BRIDGE NET intervention is theoretically informed, pragmatic, and able to be delivered virtually by a diverse clinical team. Informed by qualitative interviews with clinicians and collaboration with a community advisory board, the investigators rigorously developed, piloted and tested the BRIDGE NET intervention and tailored the approach to the unique needs of patients with SMI and cancer. To increase the reach of specialty care and the limited mental health workforce, there is a critical need for interventions that can be delivered virtually. This work has potential to be foundational for future multi-site trials across national community oncology research networks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •be ≥18 years
- •have a prior diagnosis of SMI, defined as schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with previous psychiatric hospitalization
- •have a new primary diagnosis of invasive breast, head/neck, gastrointestinal (GI), genitourinary (GU), thoracic, or gynecological cancers that can be treated with curative intent
- •be within 8 weeks of initial oncology consultation at or referral to a community cancer affiliate site of the Mass General Brigham Cancer Institute at MGH
- •be able to read and write in English, Spanish, or Portuguese
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cancer Care Disruption
Time Frame: 24 weeks
Primary outcome is the proportion of patients who experience clinically relevant disruptions (at least one delay to cancer treatment initiation, deviation from stage-appropriate cancer treatment, or interruption in planned treatment) within 24 weeks of study enrollment.
Secondary Outcomes
- Time to cancer treatment initiation(Up to 24 weeks)
- Depression (PHQ-9)(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Anxiety (GAD-7)(Baseline, 6 weeks, 12 weeks, 24 weeks)
Investigators
Kelly Edwards Irwin
Principal Investigator
Massachusetts General Hospital