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Trial Title: Adapting the Tumor Board Model for Mental Illness and Cancer

NCT ID: NCT05837598

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

Conditions: Official terms:
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms
Depression
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Mental Disorders

Conditions: Keywords:
Cancer Care
Major Depression and Cancer
Schizophrenia and Cancer
Bipolar disorder and Cancer
Lung Cancer
Breast Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Schizophrenia
Bipolar Disorder
Major Depression
Health equity
Mental disorders

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Virtual Cancer and Mental Health Tumor Board
Description: The Virtual Cancer and Mental Health Tumor Board intervention aims to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, build understanding of the person's needs and strengths, and address barriers to care. Strategies include a proactive assessment of illness understanding, psychiatric history, and barriers to care followed by development of an integrated cancer and mental health treatment plan during the tumor board session that is framed in terms of patient values and addresses barriers to accessing psycho-oncology and specialty oncology expertise. These recommendations will be shared with treating oncologists, documented in the medical record, and shared with the patient. Patients will receive a transition phone call at 12 weeks.
Arm group label: Tumor Board Arm

Summary: This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population.

Detailed description: Individuals with serious mental illness (SMI) experience increased cancer mortality because of inequities in cancer care. Access to mental health and cancer care remains inadequate. Virtual tumor boards have been associated with higher rates of patients receiving guideline-concordant cancer care, but these tumor boards have not been adapted for cancer and mental illness. A virtual cancer and mental health tumor board intervention has potential to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, and may address barriers to cancer and mental health care. The purpose of this study is to examine the feasibility and acceptability of a virtual tumor board for cancer and mental illness for our target population for patients and clinicians. We will also explore changes in cancer care, psychiatric symptoms, and clinician self-efficacy in managing this population. This study is a single-arm pilot (n = 30) based at a cancer center affiliate and the surrounding community. The intervention includes proactive identification using a registry, bi-monthly virtual equity tumor board focused on cancer and mental health using HIPAA-compliant videoconference that uses co-learning, assessment of barriers to cancer care, strengths, and goals of care, creating plans that identify who is responsible for next steps and patient communication, and relaying recommendations to patients and the treating oncology team.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years old 2. Verbal fluency in English 3. SMI (schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with either prior psychiatric hospitalization, history of suicide attempt/suicidal ideation, Medicaid insurance, and/or comorbid alcohol or opioid use disorder) confirmed by diagnostic evaluation of study psychiatrist 4. New invasive stage I-IV breast, lung, gastrointestinal, genitourinary, or head and neck cancer (highly suspected or confirmed according to documentation by the oncologist or pathology) 5. Oncology consultation at or referral to a MGH Danvers within the past 8 weeks Exclusion Criteria: 1. 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 2. Recurrence of same cancer type 3. Do not have verbal fluency in English

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mass General/North Shore Center for Outpatient Care

Address:
City: Danvers
Zip: 01923
Country: United States

Status: Recruiting

Contact:
Last name: Elizabeth P Walsh, MD
Email: EWALSH20@MGH.HARVARD.EDU

Start date: May 31, 2023

Completion date: May 31, 2024

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Collaborator:
Agency: Trefler Foundation
Agency class: Other

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05837598

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