Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network

NCT07707362 | Not Yet Recruiting DMC

• 1 other identifier: R37CA300110
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer; Serious Mental Illness

Keywords

Cancer; Serious mental illness; Collaborative care model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

BRIDGE NET Intervention Arm

ACTIVE COMPARATOR

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

Enhanced Usual Care Arm

NO INTERVENTION

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.

Interventions

BRIDGE NET OTHER

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.

BRIDGE NET Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Kelly Irwin, MD, MPH

CONTACT

617-726-2000; kirwin1@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE-NET intervention which combines features of a Phase II and Phase III trial given analysis of intervention outcomes and implementation outcomes.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share