Clinical trial NCT02594696: Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness
Official title: Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Schizophrenia
Bipolar Disorder
Lung Cancer
Breast Cancer
Head and Neck Cancer
GI Cancer
Cancer
Keywords: Major depression and Cancer
Schizophrenia and Cancer
Bipolar disorder and Cancer
Lung Cancer
Breast Cancer
Head and Neck cancer
GI cancer
Schizophrenia
Bipolar disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: National Cancer Institute (NCI)
First posted: 2015-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility of implementing the intervention in patients with SMI and cancer
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of the intervention for patients with SMI and cancer and oncology clinicians
timeFrame: 12 weeks
measure: Rates of receipt of stage-appropriate cancer treatment
timeFrame: 6 Months
measure: Rates of receipt of healthcare utilization in the outpatient setting
timeFrame: 6 Months
measure: Rates of receipt of healthcare utilization in the acute care setting
timeFrame: 6 Months
measure: Change in clinician-rated psychiatric symptoms
timeFrame: Baseline to 12 weeks post intervention
measure: Change in clinician-rated psychiatric illness severity
timeFrame: Baseline to 12 weeks post intervention
measure: Change in self-reported psychiatric symptoms
timeFrame: Baseline to 12 weeks post intervention
measure: Change in self-reported depression symptoms
timeFrame: Baseline to 12 weeks post intervention
measure: Change in quality of life
timeFrame: Baseline to 12 weeks post intervention
measure: Change in illness understanding
timeFrame: Baseline to 12 weeks post intervention
measure: Change in alliance with the oncology clinician
timeFrame: Baseline to 12 weeks post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kelly Irwin, MD
role: PRINCIPAL_INVESTIGATOR
References: