Adapting the Tumor Board Model for Mental Illness and Cancer

NCT05837598 | Unknown

• 1 other identifier: 22-593
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Patient enrollment assessed by consent rate.

  The investigators will evaluate program feasibility through patient enrollment by examining consent rates (60% of eligible patients consent).

  At baseline

• Patient trial completion assessed by number of patients who complete study assessments and trial procedures.

  The investigators will evaluate trial completion assessed by number of patients who complete study assessments and trial procedures (75% of patient participants have baseline targeted assessment, have tumor board recommendations communicated with them, and complete 12-week assessment of psychiatric symptoms and barriers to cancer care).

  12 weeks from study enrollment

• Patient satisfaction assessed by patient feedback questionnaire.

  The investigators will evaluate program acceptability through patient intervention satisfaction by a patient feedback questionnaire (exit interview surveys with participating patients regarding the usefulness of the intervention) at 12 weeks.

  12 weeks from study enrollment

Secondary Outcomes (6)

• Volume of tumor board session attendance by tumor board participants.

  24 weeks from study enrollment

• Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire.

  24 weeks from study enrollment

• Number of participants contributing to multi-disciplinary representation at tumor board sessions.

  24 weeks from study enrollment

• Percentage of tumor board participants participating in tumor board session.

  24 weeks from study enrollment

• Percentage of tumor board participants completing study questionnaires.

  24 weeks from study enrollment

Other Outcomes (8)

• Change in patient psychiatric illness severity assessed by Brief Psychiatric Rating Scale (BPRS).

  12 weeks from study enrollment

• Change in patient anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7).

  12 weeks from study enrollment

• Change in patient depression symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).

  12 weeks from study enrollment

Study Arms (1)

Tumor Board Arm

EXPERIMENTAL

This intervention has three parts: Part 1: Proactive identification and assessment of patient needs, values, psychiatric symptoms, and illness understanding Part 2: Virtual tumor board discussion o Bring together expertise in mental illness and cancer, the interdisciplinary team will co-design an integrated cancer and mental health treatment plan. Key strategies include: addressing resource-related barriers to care, framing next steps in terms of patient values, and identifying action steps to address barriers to psycho-oncology/specialty oncology expertise Part 3: Closed Loop Communication o Tumor board recommendations shared with treating oncologist, documented in medical record, and shared with patient. Team tracks steps taken to address barriers to care and follows up with patient at 12 weeks.

Behavioral: Virtual Cancer and Mental Health Tumor Board

Interventions

Virtual Cancer and Mental Health Tumor Board BEHAVIORAL

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.

Tumor Board Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Verbal fluency in English
• 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
• 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)
• Oncology consultation at or referral to a MGH Danvers within the past 8 weeks

You may not qualify if:

• 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 same cancer type
• Do not have verbal fluency in English

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Trefler Foundation: collaborator

Study Sites (1)

Mass General/North Shore Center for Outpatient Care

Danvers, Massachusetts, 01923, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Depressive Disorder, Major; Schizophrenia; Bipolar Disorder; Lung Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Urogenital Neoplasms; Mental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Kelly Irwin, MD, MPH

CONTACT

617-643-4453; kirwin1@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: May 1, 2023
• Study Start: May 31, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

US (1)