Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

Mass General Brigham

Status: Completed

Conditions: Breast Cancer; Schizophrenia; Gastrointestinal Cancer; Bipolar Disorder; Lung Cancer; Cancer; Head and Neck Cancer; Severe Major Depression

Treatments: Other: Proactive Psychiatry Consultation (PPC); Other: Enhanced Usual Care (EUC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03360695

17-396

1K08CA230185-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.

Full description

It is challenging to cope with cancer. The investigators want to understand if it is helpful for patients with serious mental illness (SMI) to be connected to a psychiatrist and case manager when cancer is diagnosed. Many people with illnesses like major depression, schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to appointments, have many different doctors, and experience depression or worry. Better communication between the patient, the oncology team, and mental health providers may improve care. As for all patients, it is important for people with mental illness to have access to high quality cancer treatment that is patient-centered and coordinated. Having a case manager and psychiatrist at the cancer center who collaborates with the oncology team starting at cancer diagnosis may help patients to receive the cancer care that they need.

This study includes a single-arm open pilot (n=8) to pilot patient and caregiver measures and refine the intervention manual; a run-in period (n=6) to pilot the randomized trial procedures; and a randomized controlled trial (n=120) to compare the impact of the Bridge model with enhanced usual care on disruptions in cancer care.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

• Age ≥ 18 years old; Value ______
• Verbal fluency in English
• Serious mental illness (Schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with prior psychiatric hospitalization) confirmed by study clinician at consent
• Invasive breast, lung, gastrointestinal, or head and neck cancer (suspected or confirmed Stage I-III, or Stage IV cancer that can be treated with curative intent according to judgment by the oncologist.)
• Medical, surgical, or radiation oncology consultation at MGH Cancer Center within the past 8 weeks or a referral placed to the MGH Cancer Center and planned or recommended follow-up

Patient Exclusion Criteria:

• Have cognitive impairment severe enough to interfere with completing brief study assessments or providing informed consent (and does not have a guardian who can provide consent)
• Recurrence of the same cancer type

Caregiver Participants

• Age ≥ 18 years old; Value ______
• Verbal fluency in English
• Identified or confirmed by the patient or guardian as a caregiver
• Caregiver may be a relative, friend, or community mental health staff upon whom the patient relies upon for support and who accompanies the patient to medical appointments
• The caregiver should either live with the patient or have in-person contact with the patient once per week (on average)
• Patient or guardian must provide permission to contact caregiver

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 3 patient groups

Proactive Psychiatry Consultation (PPC) - PILOT

Experimental group

Description:

Proactive Psychiatry Consultation and Case Management is: 1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care. 3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. 4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.

Treatment:

Other: Proactive Psychiatry Consultation (PPC)

Proactive Psychiatry Consultation (PPC) - Randomized Trial

Experimental group

Description:

Proactive Psychiatry Consultation and Case Management is: 1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care. 3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. 4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.

Treatment:

Other: Proactive Psychiatry Consultation (PPC)

Enhanced Usual Care (EUC) - Randomized Trial

Active Comparator group

Description:

Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.

Treatment:

Other: Enhanced Usual Care (EUC)