Back to resultsBridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Primary Purpose
Cancer, Severe Major Depression, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Psychiatry Consultation (PPC)
Enhanced Usual Care (EUC)
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring 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
Eligibility Criteria
Patient Inclusion Criteria:
- 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
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)
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Proactive Psychiatry Consultation (PPC) - PILOT
Proactive Psychiatry Consultation (PPC) - Randomized Trial
Enhanced Usual Care (EUC) - Randomized Trial
Arm Description
Proactive Psychiatry Consultation and Case Management is: Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 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. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. 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 and Case Management is: Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 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. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
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.
Outcomes
Primary Outcome Measures
Disruptions in Cancer Care
The proportion 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).
Secondary Outcome Measures
Patient and Caregiver Outcome Measures
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.
Full Information
NCT ID
NCT03360695
First Posted
November 28, 2017
Last Updated
July 31, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Harvard Risk Management Foundation, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03360695
Brief Title
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Official Title
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard Risk Management Foundation, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer
Keywords
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proactive Psychiatry Consultation (PPC) - PILOT
Arm Type
Experimental
Arm Description
Proactive Psychiatry Consultation and Case Management is:
Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
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.
Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Arm Title
Proactive Psychiatry Consultation (PPC) - Randomized Trial
Arm Type
Experimental
Arm Description
Proactive Psychiatry Consultation and Case Management is:
Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
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.
Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Arm Title
Enhanced Usual Care (EUC) - Randomized Trial
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proactive Psychiatry Consultation (PPC)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disruptions in Cancer Care
Description
The proportion 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).
Time Frame
6 months from study enrollment
Secondary Outcome Measure Information:
Title
Patient and Caregiver Outcome Measures
Description
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.
Time Frame
24 weeks (patients) and 12 weeks (caregivers)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria:
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
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly E Irwin, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
We'll reach out to this number within 24 hrs