CancerNCT05837598
Adapting the Tumor Board Model for Mental Illness and Cancer
A study testing Virtual Cancer and Mental Health Tumor Board in people with Cancer and Severe Major Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Severe Major Depression, Schizophrenia
- What is being tested?
- Virtual Cancer and Mental Health Tumor Board
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mass General/North Shore Center for Outpatient Care
Danvers, Massachusetts, 01923
Elizabeth P Walsh, MD, EWALSH20@MGH.HARVARD.EDU
About this study
Official title: Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial
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.
Read the 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.
- Conditions
- Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer
- Being tested
- Virtual Cancer and Mental Health Tumor Board
- 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
- Medical subject headings
- Neoplasms, Depressive Disorder, Major, Schizophrenia, Bipolar Disorder, Lung Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Cancer and Mental Health Tumor BoardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Cancer and Mental Health Tumor Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment assessed by consent rate.
The investigators will evaluate program feasibility through patient enrollment by examining consent rates (60% of eligible patients consent).
Measured: 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).
Measured: 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.
Measured: 12 weeks from study enrollment
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 weeks from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start31 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trefler Foundation
- Responsible party
- Principal investigator, Kelly Edwards Irwin, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837598
- Sponsor's protocol ID
- 22-593
- Status last verified
- Aug 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial
- ClinicalTrials.gov ID
- NCT05837598
- Acronym / sponsor ID
- 22-593
- Conditions
- Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Trefler Foundation
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Board Arm | Experimental | Behavioral: Virtual Cancer and Mental Health Tumor BoardThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Cancer and Mental Health Tumor BoardThe 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. | Behavioural | Tumor Board Arm |
Primary outcome
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).
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).
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.
6 secondary outcomes
Volume of tumor board session attendance by tumor board participants.
Time frame: 24 weeks from study enrollment
Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire.
Time frame: 24 weeks from study enrollment
Number of participants contributing to multi-disciplinary representation at tumor board sessions.
Time frame: 24 weeks from study enrollment
Percentage of tumor board participants participating in tumor board session.
Time frame: 24 weeks from study enrollment
Percentage of tumor board participants completing study questionnaires.
Time frame: 24 weeks from study enrollment
Tumor board participant satisfaction assessed by in-session feedback questionnaire.
Time frame: 24 weeks from study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Cancer and Mental Health Tumor Board in people with Cancer and Severe Major Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Irwin, MD, MPH (617-643-4453, kirwin1@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment assessed by consent rate. (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.