Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

Not Applicable

Completed

Conditions: Cancer
Bipolar Disorder
Head and Neck Cancer
Breast Cancer
Schizophrenia
Lung Cancer
Gastrointestinal Cancer
Severe Major Depression

Interventions: Other: Proactive Psychiatry Consultation (PPC)
Other: Enhanced Usual Care (EUC)

Registration Number: NCT03360695

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive Psychiatry Consultation (PPC) - PILOT	Proactive Psychiatry Consultation (PPC)	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) - Randomized Trial	Proactive Psychiatry Consultation (PPC)	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.
Enhanced Usual Care (EUC) - Randomized Trial	Enhanced Usual Care (EUC)	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.

Primary Outcome Measures

Name	Time	Method
Disruptions in Cancer Care	6 months from study enrollment	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).

Secondary Outcome Measures

Name	Time	Method
PHQ-9	Week 0, Week 6, Week 12, Week 24	Patient Health Questionnaire-9 is a 9-item instrument that measures patient depression where a score of 1-4 indicates minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression. The minimum score is 1 and the maximum score is 27.
BPRS (24)	Week 0, Week 12, Week 24	Brief Psychiatric Rating Scale (BPRS) 24 24-item instrument where the rater enters a number for each symptom. Each symptom construct is rated on a Likert scale from 1 (NOT PRESENT) - 7 (EXTREMELY SEVERE). The sum of all 24 items is then calculated to a maximum score of 168 (24X7=168). The minimum score is 24 and the maximum score is 168. The higher the score, the more psychiatrically impaired the patient is. Higher scores mean worse psychiatric symptoms.