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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

November 28, 2017
December 4, 2017
February 1, 2018
December 11, 2017
March 30, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03360695 on ClinicalTrials.gov Archive Site
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
Same as current
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 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).
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
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)

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
Same as current
July 30, 2018
March 30, 2018   (Final data collection date for primary outcome measure)

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
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
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
Principal Investigator: Kelly E Irwin, MD Massachusetts General Hospital
Massachusetts General Hospital
January 2018

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