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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 : May 13, 2019
Sponsor:
Collaborators:
Harvard Risk Management Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kelly Edwards Irwin, Massachusetts General Hospital

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.


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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 : May 15, 2022
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proactive Psychiatry Consultation (PPC) - PILOT

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.
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:

  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.
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.




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; 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 according to documentation by the oncologist or pathology)
  • 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

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

Locations
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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
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Principal Investigator: Kelly E Irwin, MD Massachusetts General Hospital

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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: May 13, 2019
Last Verified: May 2019
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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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