Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
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ClinicalTrials.gov Identifier: NCT03360695 |
Recruitment Status :
Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cancer Severe Major Depression Schizophrenia Bipolar Disorder Lung Cancer Breast Cancer Head and Neck Cancer Gastrointestinal Cancer | Other: Proactive Psychiatry Consultation (PPC) Other: Enhanced Usual Care (EUC) | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 265 participants |
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. |
Primary Purpose: | Supportive Care |
Official Title: | Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer |
Actual Study Start Date : | December 11, 2017 |
Estimated Primary Completion Date : | July 31, 2022 |
Estimated Study Completion Date : | August 15, 2023 |

Arm | Intervention/treatment |
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Experimental: Proactive Psychiatry Consultation (PPC) - PILOT
Proactive Psychiatry Consultation and Case Management is:
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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. |
Experimental: Proactive Psychiatry Consultation (PPC) - Randomized Trial
Proactive Psychiatry Consultation and Case Management is:
|
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. |
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 and caregiver of available psychosocial services.
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Other: 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. |
- Disruptions in Cancer Care [ Time Frame: 6 months from study enrollment ]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).
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360695
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Kelly E Irwin, MD | Massachusetts General Hospital |
Responsible Party: | Kelly Edwards Irwin, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT03360695 |
Other Study ID Numbers: |
17-396 1K08CA230185-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 4, 2017 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Head and Neck Neoplasms Gastrointestinal Neoplasms Depression Schizophrenia Bipolar Disorder Depressive Disorder, Major Neoplasms by Site Neoplasms Behavioral Symptoms |
Depressive Disorder Mood Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |