Clinical trial NCT03360695: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Risk Management Foundation
name: National Cancer Institute (NCI)
First posted: 2017-12-04
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Disruptions in Cancer Care
timeFrame: 6 months from study enrollment
Secondary outcomes:
measure: BPRS (24)
timeFrame: Week 0, Week 12, Week 24
measure: PHQ-9
timeFrame: Week 0, Week 6, Week 12, Week 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kelly E Irwin, MD
role: PRINCIPAL_INVESTIGATOR
References: