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

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ClinicalTrials.gov Identifier: NCT03360695

Recruitment Status : Active, not recruiting

First Posted : December 4, 2017

Last Update Posted : January 13, 2022

Sponsor:

Collaborators:

Harvard Risk Management Foundation

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Kelly Edwards Irwin, Massachusetts General Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cancer Severe Major Depression Schizophrenia Bipolar Disorder Lung Cancer Breast Cancer Head and Neck Cancer Gastrointestinal Cancer	Other: Proactive Psychiatry Consultation (PPC) Other: Enhanced Usual Care (EUC)	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	265 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	1. A consensus panel of disease-specific oncologists who are blinded to intervention arm will review all patients at 24 weeks of care and evaluate for disruptions in cancer care.
Primary Purpose:	Supportive Care
Official Title:	Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Actual Study Start Date :	December 11, 2017
Estimated Primary Completion Date :	July 31, 2022
Estimated Study Completion Date :	August 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bipolar disorder Schizophrenia Depression

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Proactive Psychiatry Consultation (PPC) - PILOT 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) 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.
Experimental: Proactive Psychiatry Consultation (PPC) - Randomized Trial 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) 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.
Active Comparator: Enhanced Usual Care (EUC) - Randomized Trial 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) 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.

Outcome Measures

Primary Outcome Measures :

Disruptions in Cancer Care [ Time Frame: 6 months from study enrollment ]
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).

Secondary Outcome Measures :

Patient and Caregiver Outcome Measures [ Time Frame: 24 weeks (patients) and 12 weeks (caregivers) ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360695

Locations

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Harvard Risk Management Foundation

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	Kelly E Irwin, MD	Massachusetts General Hospital

More Information

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Responsible Party:	Kelly Edwards Irwin, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT03360695
Other Study ID Numbers:	17-396 1K08CA230185-01 ( U.S. NIH Grant/Contract )
First Posted:	December 4, 2017 Key Record Dates
Last Update Posted:	January 13, 2022
Last Verified:	January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Kelly Edwards Irwin, Massachusetts General Hospital:


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

Additional relevant MeSH terms:

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Head and Neck Neoplasms Gastrointestinal Neoplasms Depression Schizophrenia Bipolar Disorder Depressive Disorder, Major Neoplasms by Site Neoplasms Behavioral Symptoms	Depressive Disorder Mood Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases

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