Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network (BRIDGE-NET)

Improving Care Delivery for Individuals With Mental Illness and Cancer Across a Cancer Center Network: A Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Serious Mental Illness
• Intervention / Treatment: Other: BRIDGE NET

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 Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Irwin, MD, MPH; Phone Number: 617-726-2000; Email: kirwin1@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. be ≥18 years
2. have a prior diagnosis of SMI, defined as schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with previous psychiatric hospitalization
3. 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
4. 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
5. be able to read and write in English, Spanish, or Portuguese

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BRIDGE NET Intervention Arm; BRIDGE NET is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers.	Other: BRIDGE NET; BRIDGE is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers. Modules include Evaluation, Treatment Planning, Weekly Outreach, Biweekly Outreach, and Transition Planning.
No Intervention: Enhanced Usual Care Arm; EUC includes proactive identification of patients with SMI and a new cancer diagnosis, sending a templated email to the oncologist describing the patient's primary psychiatric diagnosis (e.g. schizophrenia, bipolar disorder, or major depression), and informing the patient of psychosocial services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Care Disruption	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to cancer treatment initiation	Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation).	Up to 24 weeks
Depression (PHQ-9)	The PHQ-9 (Patient Health Questionnaire-9) is a standardized, 9-item self-report tool used by healthcare providers to screen for, diagnose, and measure the severity of depression. Higher score indicates more severe depression symptoms (minimum 0, maxiumum 27).	Baseline, 6 weeks, 12 weeks, 24 weeks
Anxiety (GAD-7)	The GAD-7 (Generalized Anxiety Disorder-7) is a brief 7-item questionnaire used by healthcare providers to screen for Generalized Anxiety Disorder and measure the severity of anxiety symptoms. Higher scores indicate higher anxiety symptoms. (Minimum score 0, Maximum score 21).	Baseline, 6 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Serious mental illness; Collaborative care model
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: R37CA300110 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If the results of this research study are published in a medical journal, they will not identify individual patients in the interest of protecting patient privacy and confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No