Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05837598

Conditions

Cancer

Severe Major Depression

Schizophrenia

Bipolar Disorder

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Cancer and Mental Health Tumor Board

Study Details

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

Study ID

NCT05837598

Start date

May 31, 2023

Status verified date

Aug, 2023

Completion date

May 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years old
2. Verbal fluency in English
3. 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
4. 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)
5. Oncology consultation at or referral to a MGH Danvers within the past 8 weeks

Exclusion Criteria:

1. 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
2. Recurrence of same cancer type
3. Do not have verbal fluency in English

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Virtual Cancer and Mental Health Tumor Board

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

  • Patient enrollment assessed by consent rate. [ Time Frame: At baseline ]
  • Patient trial completion assessed by number of patients who complete study assessments and trial procedures. [ Time Frame: 12 weeks from study enrollment ]
  • Patient satisfaction assessed by patient feedback questionnaire. [ Time Frame: 12 weeks from study enrollment ]

Central Contacts and Locations

Central contacts

Kelly Irwin, MD, MPH

617-643-4453kirwin1@partners.org

Locations

Mass General/North Shore Center for Outpatient Care

Recruiting

Danvers, Massachusetts, United States, 01923

Contacts

Elizabeth P Walsh, MD

EWALSH20@MGH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 3, 2023

Last verified

Aug, 2023

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-08-03.