Clinical trial NCT05837598: Adapting the Tumor Board Model for Mental Illness and Cancer
Official title: Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Severe Major Depression
Schizophrenia
Bipolar Disorder
Lung Cancer
Breast Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Genitourinary 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
Genitourinary Cancer
Schizophrenia
Bipolar Disorder
Major Depression
Health equity
Mental disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Trefler Foundation
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Patient enrollment assessed by consent rate.
timeFrame: At baseline
measure: Patient trial completion assessed by number of patients who complete study assessments and trial procedures.
timeFrame: 12 weeks from study enrollment
measure: Patient satisfaction assessed by patient feedback questionnaire.
timeFrame: 12 weeks from study enrollment
Secondary outcomes:
measure: Volume of tumor board session attendance by tumor board participants.
timeFrame: 24 weeks from study enrollment
measure: Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire.
timeFrame: 24 weeks from study enrollment
measure: Number of participants contributing to multi-disciplinary representation at tumor board sessions.
timeFrame: 24 weeks from study enrollment
measure: Percentage of tumor board participants participating in tumor board session.
timeFrame: 24 weeks from study enrollment
measure: Percentage of tumor board participants completing study questionnaires.
timeFrame: 24 weeks from study enrollment
measure: Tumor board participant satisfaction assessed by in-session feedback questionnaire.
timeFrame: 24 weeks from study enrollment
Other outcomes:
measure: Change in patient psychiatric illness severity assessed by Brief Psychiatric Rating Scale (BPRS).
timeFrame: 12 weeks from study enrollment
measure: Change in patient anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7).
timeFrame: 12 weeks from study enrollment
measure: Change in patient depression symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).
timeFrame: 12 weeks from study enrollment
measure: Change in patient quality of life assessed by Functional Assessment of Cancer Therapy - General (FACT-G).
timeFrame: 12 weeks from study enrollment
measure: Change in tumor board participant self-efficacy assessed by Tumor Board Participant Self-Efficacy Assessment.
timeFrame: 24 weeks from study enrollment
measure: Change in tumor board participant burnout assessed by modified Maslach Burnout Inventory survey.
timeFrame: 24 weeks from study enrollment
measure: Disruptions in patient cancer care assessed by electronic medical record review.
timeFrame: 24 weeks from study enrollment
measure: Patient receipt of mental health care assess by electronic medical record review.
timeFrame: 24 weeks from study enrollment
Locations:
city: Danvers
country: United States
facility: Mass General/North Shore Center for Outpatient Care
state: Massachusetts
Study officials:
References: