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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 : September 5, 2018
Sponsor:
Collaborators:
Harvard Risk Management Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kelly Edwards Irwin, Massachusetts General Hospital

November 28, 2017
December 4, 2017
September 5, 2018
December 11, 2017
October 30, 2021   (Final data collection date for primary outcome measure)
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).
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
Complete list of historical versions of study NCT03360695 on ClinicalTrials.gov Archive Site
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.

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
Not Provided
Not Provided
 
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
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.

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.

Interventional
Not Applicable
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.
  2. 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
  • Cancer
  • Severe Major Depression
  • Schizophrenia
  • Bipolar Disorder
  • Lung Cancer
  • Breast Cancer
  • Head and Neck Cancer
  • Gastrointestinal Cancer
  • 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.
  • 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.
  • 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.
    Intervention: Other: Proactive Psychiatry Consultation (PPC)
  • 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.
    Intervention: Other: Proactive Psychiatry Consultation (PPC)
  • 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.
    Intervention: Other: Enhanced Usual Care (EUC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
265
9
January 30, 2022
October 30, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Kelly E Irwin, MD 617-643-4453 keirwin@partners.org
United States
 
 
NCT03360695
17-396
1K08CA230185-01 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Kelly Edwards Irwin, Massachusetts General Hospital
Massachusetts General Hospital
  • Harvard Risk Management Foundation
  • National Cancer Institute (NCI)
Principal Investigator: Kelly E Irwin, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP