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Adapting the Tumor Board Model for Mental Illness and Cancer

Primary Purpose

Cancer, Severe Major Depression, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Cancer and Mental Health Tumor Board
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mass General/North Shore Center for Outpatient CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tumor Board Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).

Full Information

First Posted
February 21, 2023
Last Updated
August 1, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Trefler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05837598
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Trefler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumor Board Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Cancer and Mental Health Tumor Board
Intervention 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.
Primary Outcome Measure Information:
Title
Patient enrollment assessed by consent rate.
Description
The investigators will evaluate program feasibility through patient enrollment by examining consent rates (60% of eligible patients consent).
Time Frame
At baseline
Title
Patient trial completion assessed by number of patients who complete study assessments and trial procedures.
Description
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).
Time Frame
12 weeks from study enrollment
Title
Patient satisfaction assessed by patient feedback questionnaire.
Description
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.
Time Frame
12 weeks from study enrollment
Secondary Outcome Measure Information:
Title
Volume of tumor board session attendance by tumor board participants.
Description
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).
Time Frame
24 weeks from study enrollment
Title
Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire.
Description
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).
Time Frame
24 weeks from study enrollment
Title
Number of participants contributing to multi-disciplinary representation at tumor board sessions.
Description
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).
Time Frame
24 weeks from study enrollment
Title
Percentage of tumor board participants participating in tumor board session.
Description
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).
Time Frame
24 weeks from study enrollment
Title
Percentage of tumor board participants completing study questionnaires.
Description
The investigators will evaluate program feasibility by examining completion of study measures (70% of participants complete 12-week- and 24-week measures).
Time Frame
24 weeks from study enrollment
Title
Tumor board participant satisfaction assessed by in-session feedback questionnaire.
Description
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).
Time Frame
24 weeks from study enrollment
Other Pre-specified Outcome Measures:
Title
Change in patient psychiatric illness severity assessed by Brief Psychiatric Rating Scale (BPRS).
Description
Investigators will assess change in patient psychiatric illness severity using the Brief Psychiatric Rating Scale (BPRS). This questionnaire is 24 items, each question rated on a 7-point scale of severity ranging from "not present" to "extremely severe." Scores vary from 24 to 168 with higher scores indicating more severe psychiatric illness.
Time Frame
12 weeks from study enrollment
Title
Change in patient anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7).
Description
Investigators will assess change in patient anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7). This questionnaire is 7 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 21, with higher scores indicating greater anxiety.
Time Frame
12 weeks from study enrollment
Title
Change in patient depression symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).
Description
Investigators will assess change in patient depression symptoms using the Patient Health Questionnaire-9 (PHQ-9). This questionnaire is 9 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 27, with higher scores indicating greater depression.
Time Frame
12 weeks from study enrollment
Title
Change in patient quality of life assessed by Functional Assessment of Cancer Therapy - General (FACT-G).
Description
Investigators will assess change in patient quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G). This questionnaire is 27 items, and response are on a 5-point rating scale from "0" (not at all) to "4" (very much). Scores range from 0 - 108, and higher scores indicate better quality of life.
Time Frame
12 weeks from study enrollment
Title
Change in tumor board participant self-efficacy assessed by Tumor Board Participant Self-Efficacy Assessment.
Description
Investigators will assess change in tumor board participant self-efficacy using the Tumor Board Participant Self-Efficacy Assessment. This questionnaire is 22 items, with scores ranging from 0 - 44, and higher scores indicating more self-efficacy.
Time Frame
24 weeks from study enrollment
Title
Change in tumor board participant burnout assessed by modified Maslach Burnout Inventory survey.
Description
Investigators will assess change in tumor board participant burnout using a modified Maslach Burnout Inventory survey. This questionnaire is 22 items, and responses range from "0" (never) to "6" (every day). Section A scores range from 0 - 42, with a higher score indicating more burnout. Section B scores range from 0 - 42, with a higher score indicating more burnout. Section C scores range from 0 - 48, with a higher score indicating less burnout.
Time Frame
24 weeks from study enrollment
Title
Disruptions in patient cancer care assessed by electronic medical record review.
Description
Number of participants with Disruptions in patient cancer care assessed by electronic medical record review. Disruptions are defined as delays, deviations in cancer care recommended, and interruptions in planned cancer treatment.
Time Frame
24 weeks from study enrollment
Title
Patient receipt of mental health care assess by electronic medical record review.
Description
Number of participants with documented receipt of mental health care for patients assessed by electronic medical record review.
Time Frame
24 weeks from study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Irwin, MD, MPH
Phone
617-643-4453
Email
kirwin1@partners.org
Facility Information:
Facility Name
Mass General/North Shore Center for Outpatient Care
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth P Walsh, MD
Email
EWALSH20@MGH.HARVARD.EDU

12. IPD Sharing Statement

Learn more about this trial

Adapting the Tumor Board Model for Mental Illness and Cancer

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