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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: Proactive Psychiatry Consultation (PPC)
* Other: Enhanced Usual Care (EUC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive Psychiatry Consultation (PPC) - PILOT<br>Proactive Psychiatry Consultation and Case Management is: Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 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. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. | Other: Proactive Psychiatry Consultation (PPC)<br>* Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.<br>|
| Experimental: Proactive Psychiatry Consultation (PPC) - Randomized Trial<br>Proactive Psychiatry Consultation and Case Management is: Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 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. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. | Other: Proactive Psychiatry Consultation (PPC)<br>* Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.<br>|
| Active Comparator: Enhanced Usual Care (EUC) - Randomized Trial<br>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. | Other: Enhanced Usual Care (EUC)<br>* At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disruptions in Cancer Care | The proportion of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment). | 6 months from study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Caregiver Outcome Measures | Patients: clinicians assess psychiatric symptoms and illness; patients self-report depression and anxiety, satisfaction with cancer care, activation, and symptom burden. Caregivers: self-report depression and anxiety, satisfaction with patient's cancer care, caregiver burden, mastery, and activation. | 24 weeks (patients) and 12 weeks (caregivers) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Care, Major Depression and Cancer, Schizophrenia and Cancer, Bipolar Disorder and Cancer, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Schizophrenia, Bipolar Disorder, Major Depression