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临床试验/NCT05837598
NCT05837598招募中不适用

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

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Patient enrollment assessed by consent rate.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Patient enrollment assessed by consent rate.

时间窗: At baseline

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

Patient satisfaction assessed by patient feedback questionnaire.

时间窗: 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.

Patient trial completion assessed by number of patients who complete study assessments and trial procedures.

时间窗: 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).

次要结局

  • Percentage of tumor board participants participating in tumor board session.(24 weeks from study enrollment)
  • Tumor board participant satisfaction assessed by in-session feedback questionnaire.(24 weeks from study enrollment)
  • Number of participants contributing to multi-disciplinary representation at tumor board sessions.(24 weeks from study enrollment)
  • Volume of tumor board session attendance by tumor board participants.(24 weeks from study enrollment)
  • Tumor board participant satisfaction assessed by tumor board participant feedback questionnaire.(24 weeks from study enrollment)
  • Percentage of tumor board participants completing study questionnaires.(24 weeks from study enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Edwards Irwin

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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