- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05837598
Adapting the Tumor Board Model for Mental Illness and Cancer
Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kelly Irwin, MD, MPH
- Phone Number: 617-643-4453
- Email: kirwin1@partners.org
Study Locations
-
-
Massachusetts
-
Danvers, Massachusetts, United States, 01923
- Recruiting
- Mass General/North Shore Center for Outpatient Care
-
Contact:
- Elizabeth P Walsh, MD
- Email: EWALSH20@MGH.HARVARD.EDU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tumor Board Arm
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient enrollment assessed by consent rate.
Time Frame: At baseline
|
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.
Time Frame: 12 weeks from study enrollment
|
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.
Time Frame: 12 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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.
Time Frame: 24 weeks from study enrollment
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient psychiatric illness severity assessed by Brief Psychiatric Rating Scale (BPRS).
Time Frame: 12 weeks from study enrollment
|
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.
|
12 weeks from study enrollment
|
Change in patient anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7).
Time Frame: 12 weeks from study enrollment
|
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.
|
12 weeks from study enrollment
|
Change in patient depression symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).
Time Frame: 12 weeks from study enrollment
|
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.
|
12 weeks from study enrollment
|
Change in patient quality of life assessed by Functional Assessment of Cancer Therapy - General (FACT-G).
Time Frame: 12 weeks from study enrollment
|
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.
|
12 weeks from study enrollment
|
Change in tumor board participant self-efficacy assessed by Tumor Board Participant Self-Efficacy Assessment.
Time Frame: 24 weeks from study enrollment
|
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.
|
24 weeks from study enrollment
|
Change in tumor board participant burnout assessed by modified Maslach Burnout Inventory survey.
Time Frame: 24 weeks from study enrollment
|
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.
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24 weeks from study enrollment
|
Disruptions in patient cancer care assessed by electronic medical record review.
Time Frame: 24 weeks from study enrollment
|
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.
|
24 weeks from study enrollment
|
Patient receipt of mental health care assess by electronic medical record review.
Time Frame: 24 weeks from study enrollment
|
Number of participants with documented receipt of mental health care for patients assessed by electronic medical record review.
|
24 weeks from study enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Digestive System Diseases
- Mood Disorders
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Depressive Disorder
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Depression
- Head and Neck Neoplasms
- Schizophrenia
- Mental Disorders
- Bipolar Disorder
- Gastrointestinal Neoplasms
- Depressive Disorder, Major
- Urogenital Neoplasms
Other Study ID Numbers
- 22-593
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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