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

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ClinicalTrials.gov Identifier: NCT03360695

Recruitment Status : Recruiting

First Posted : December 4, 2017

Last Update Posted : September 5, 2018

See Contacts and Locations

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


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	265 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	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. The 12-week assessment of the BPRS will be completed by an independent study assessor who is blinded to intervention arm.
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 :	October 30, 2021
Estimated Study Completion Date :	January 30, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Bipolar disorder Depression Schizophrenia

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 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 both the oncologist and the patient 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 (defined as at least one 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

Information from the National Library of Medicine

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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
Verbal fluency in English
Serious Mental Illness (Schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with prior psychiatric hospitalization) confirmed by diagnostic evaluation of study psychiatrist
Invasive breast, lung, gastrointestinal, or head and neck cancer (suspected or confirmed according to documentation by the oncologist or pathology) treated with curable intent
Medical, surgical, or radiation oncology consultation at Massachusetts General Hospital (MGH) Cancer Center within the past 8 weeks

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)

Caregiver Participants

Age > 18 years old
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 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 participant identifies or confirms caregiver's involvement, provides 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

Contacts


Contact: Kelly E Irwin, MD	617-643-4453	keirwin@partners.org

Locations


United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kelly E Irwin, MD 617-643-4453 keirwin@partners.org
Principal Investigator: Kelly E Irwin, MD

Sponsors and Collaborators

Massachusetts General Hospital

Harvard Risk Management Foundation

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Kelly E Irwin, MD	Massachusetts General Hospital

More Information


Responsible Party:	Kelly Edwards Irwin, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT03360695 History of Changes
Other Study ID Numbers:	17-396 1K08CA230185-01 ( U.S. NIH Grant/Contract )
First Posted:	December 4, 2017 Key Record Dates
Last Update Posted:	September 5, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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:


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

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