Adapting the Tumor Board Model for Mental Illness and Cancer

Study Overview
=================
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.

Official Title
-----------------
Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial

Conditions
-----------------
Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Genitourinary Cancer

Intervention / Treatment
-----------------
* Behavioral: Virtual Cancer and Mental Health Tumor Board


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 same cancer type Do not have verbal fluency in English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor Board Arm<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of tumor board session attendance by tumor board participants. | The investigators will evaluate program feasibility by tracking volume of tumor board session attendance (feasibility defined as participants attending 80% of sessions when patients/clients discussed). | 24 weeks from study enrollment | 
| Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire. | The investigators will evaluate program acceptability by examining participant intervention satisfaction (feedback questionnaire at end of study period regarding the acceptability and helpfulness of the virtual tumor board model). | 24 weeks from study enrollment | 
| Number of participants contributing to multi-disciplinary representation at tumor board sessions. | The investigators will evaluate program feasibility by examining the amount of multi-disciplinary representation at tumor board sessions (>70% of sessions include representation from oncology/cancer center affiliate, community mental health, and psycho-oncology). | 24 weeks from study enrollment | 
| Percentage of tumor board participants participating in tumor board session. | The investigators will evaluate program feasibility by tracking percentage of tumor board participants participating in tumor board sessions (80% of participants complete intra-session feedback questionnaire). | 24 weeks from study enrollment | 
| Percentage of tumor board participants completing study questionnaires. | The investigators will evaluate program feasibility by examining completion of study measures (70% of participants complete 12-week- and 24-week measures). | 24 weeks from study enrollment | 
| Tumor board participant satisfaction assessed by in-session feedback questionnaire. | The investigators will evaluate program acceptability by examining participant intervention satisfaction (in-session feedback questionnaire regarding the acceptability and helpfulness of the virtual tumor board model). | 24 weeks from study enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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