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Clinical Trials/NCT02594696
NCT02594696
Completed
Not Applicable

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

Massachusetts General Hospital1 site in 1 country30 target enrollmentNovember 9, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression
Sponsor
Massachusetts General Hospital
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of implementing the intervention in patients with SMI and cancer
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are dying younger than the general population; cancer is a leading cause of death in this population. People with SMI have higher rates of dying from breast, lung, and colon cancer, and disparities in treatment appear to be one contributing factor. Individuals with SMI may be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate cancer treatment. Although collaborative care models integrating medical and psychiatric care have shown promise in other populations, the challenge of treating SMI and cancer is distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can impact their understanding of their diagnosis and treatment decisions. Oncologists have less training and inadequate time to address multiple unmet needs. Mental health care is frequently fragmented from cancer care.

The investigators want to understand if it is helpful for patients with SMI to be connected to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms and facilitating communication between the patient, the oncology team, and mental health providers may improve care. The goal is to pilot a pragmatic intervention for patients with cancer and SMI that can be integrated into cancer care, is acceptable to patients and oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an underserved population.

Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will follow the patient and communicate with the oncology team during the 12 week intervention. All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment received and healthcare utilization will be assessed at 6 months post-intervention.

Detailed Description

Specific Aims: Aim 1: To evaluate the feasibility and acceptability of proactive psychiatry consultation and case management among individuals with SMI treated at the MGH Cancer Center and their oncology clinicians. Aim 2: To describe the rates of receipt of stage-appropriate cancer treatment and patterns of healthcare utilization in patients with SMI and cancer who are receiving the intervention Aim 3: To explore patterns of change in psychiatric symptoms, quality of life, illness understanding, and alliance with the oncology clinician in patients with SMI and a recent cancer diagnosis who are receiving the intervention.

Registry
clinicaltrials.gov
Start Date
November 9, 2015
End Date
November 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Edwards Irwin

Instructor, Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Individuals with a diagnosis of a primary psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder), bipolar disorder, or major depressive disorder with prior psychiatric hospitalization, confirmed by diagnostic assessment of the PI, a psychiatrist with expertise in SMI and cancer
  • Within 8 weeks of initial oncology consultation at the MGH Cancer Center (patients who come for a second opinion and opt to have their cancer treatment at MGH will be considered eligible, patients who have been treated previously for other types of cancer will be considered eligible).
  • Age \>18 years old, verbal fluency in English
  • Suspected or newly diagnosed lung, GI, head/neck, or breast cancer documented in initial oncology note or confirmed by pathology

Exclusion Criteria

  • Cognitive impairment severe enough to interfere with completing the study assessments or providing informed consent
  • History of dementia or traumatic brain injury
  • Refuse participation

Outcomes

Primary Outcomes

Feasibility of implementing the intervention in patients with SMI and cancer

Time Frame: 12 weeks

Feasibility of participating in the intervention: * At least 75% of intervention participants complete the psychiatric diagnostic assessment and establish contact with the case manager * At least 75% of enrolled patients complete the patient-reported measures. Feasibility of enrollment process: • At least 50% of patients who are approached enroll in the intervention

Secondary Outcomes

  • Change in clinician-rated psychiatric symptoms(Baseline to 12 weeks post intervention)
  • Change in alliance with the oncology clinician(Baseline to 12 weeks post intervention)
  • Rates of receipt of healthcare utilization in the acute care setting(6 Months)
  • Change in self-reported psychiatric symptoms(Baseline to 12 weeks post intervention)
  • Acceptability of the intervention for patients with SMI and cancer and oncology clinicians(12 weeks)
  • Rates of receipt of healthcare utilization in the outpatient setting(6 Months)
  • Change in clinician-rated psychiatric illness severity(Baseline to 12 weeks post intervention)
  • Change in quality of life(Baseline to 12 weeks post intervention)
  • Change in illness understanding(Baseline to 12 weeks post intervention)
  • Rates of receipt of stage-appropriate cancer treatment(6 Months)
  • Change in self-reported depression symptoms(Baseline to 12 weeks post intervention)

Study Sites (1)

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