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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 : February 1, 2018
Sponsor:
Collaborator:
Harvard Risk Management Foundation
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 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 single-arm open pilot study will enable the study team to pilot patient measures (engagement and satisfaction in care, psychiatric and cancer-related symptoms) and caregiver measures (engagement and satisfaction in care, caregiver burden, and mastery) and refine the intervention manual before conducting a randomized controlled trial (17-396-RCT).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 : March 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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
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.



Primary Outcome Measures :
  1. Feasibility of intervention delivery [ Time Frame: 12 weeks ]

    60% of enrolled patients complete the intervention:

    1. Patient completes interdisciplinary assessment and has at least 2 additional interactions with the intervention team
    2. Intervention team communicates with oncology team at least once
    3. If caregiver identified, intervention team communicates with caregiver at least once


Secondary Outcome Measures :
  1. Acceptability of the intervention [ Time Frame: 12 weeks ]
    The intervention will be evaluated as acceptable to patients if 60% of patients rate the intervention as acceptable (at least 4/5 on a 5 point scale) in exit surveys



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

Patient Inclusion Criteria:

  • Age > 18 years old
  • Verbal fluency in English
  • SMI (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)
  • 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)
  • Refuse participation

Caregiver Participants

  • Age > 18 years old
  • Verbal fluency in English
  • Family or community-based caregiver who accompanies the patient to medical appointments or participates in decision-making about cancer care
  • Patient participant identifies or confirms caregiver's involvement, provides 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
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
Investigators
Principal Investigator: Kelly E Irwin, MD Massachusetts General Hospital

Responsible Party: Kelly Edwards Irwin, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03360695     History of Changes
Other Study ID Numbers: 17-396
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 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