Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
2 other identifiers
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Dec 2017
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedStudy Start
First participant enrolled
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
February 8, 2024
CompletedFebruary 8, 2024
February 1, 2024
4.9 years
November 28, 2017
November 8, 2023
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disruptions in Cancer Care
The number 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).
6 months from study enrollment
Secondary Outcomes (2)
BPRS (24)
Week 0, Week 12, Week 24
PHQ-9
Week 0, Week 6, Week 12, Week 24
Study Arms (3)
Proactive Psychiatry Consultation (PPC) - PILOT
EXPERIMENTALProactive 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.
Proactive Psychiatry Consultation (PPC) - Randomized Trial
EXPERIMENTALProactive 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.
Enhanced Usual Care (EUC) - Randomized Trial
ACTIVE COMPARATORStudy 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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, or Stage IV cancer that can be treated with curative intent according to judgment by the oncologist.)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Harvard Risk Management Foundationcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Irwin KE, Callaway CA, Corveleyn AE, Pappano CR, Barry MJ, Tiersma KM, Nelson ZE, Fields LE, Pirl WF, Greer JA, Temel JS, Ryan DP, Nierenberg AA, Park ER. Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer. Contemp Clin Trials. 2022 Dec;123:106975. doi: 10.1016/j.cct.2022.106975. Epub 2022 Oct 25.
PMID: 36307008DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelly Irwin, MD, MPH
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly E Irwin, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 4, 2017
Study Start
December 11, 2017
Primary Completion
November 8, 2022
Study Completion
December 1, 2022
Last Updated
February 8, 2024
Results First Posted
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share