Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
NCT ID: NCT03360695
Last Updated: 2024-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2017-12-11
2022-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Harvard Risk Management Foundation
OTHER
National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Kelly Edwards Irwin
Principal Investigator
Principal Investigators
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Kelly E Irwin, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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17-396
Identifier Type: -
Identifier Source: org_study_id
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