Overview

This trial is active, not recruiting.

Conditions major depression, schizophrenia, bipolar disorder, lung cancer, breast cancer, head and neck cancer, gi cancer, cancer
Treatment proactive psychiatry consultation (ppc)
Sponsor Massachusetts General Hospital
Collaborator American Cancer Society, Inc.
Start date October 2015
End date October 2017
Trial size 30 participants
Trial identifier NCT02594696, 15-293, 5R25CA092203-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
The patient is linked to a psychiatrist and case manager at cancer diagnosis who deliver team-based, patient-centered care. The psychiatrist collaborates with the oncologist to guide cancer treatment. The psychiatrist and case manager proactively monitor patient symptoms and potential barriers to care and remain in communication with the patient, oncology team, and community-based providers for the duration of the intervention. Patients complete study assessments at baseline, 4 +/- 2 weeks after baseline, and post-intervention (12 +/-2 weeks after baseline) Oncologists provide feedback about the usefulness of the intervention (12 +/- 2 weeks after baseline)
proactive psychiatry consultation (ppc)
The psychiatrist conducts a tailored, cancer-specific assessment to optimize psychiatric symptoms and collaborates with the oncologist to develop and modify the cancer treatment plan. The case manager, a social worker, engages with the patient to promote self-management, identify and address barriers to care, and bridge communication with oncology and mental health. The psychiatrist and case manager proactively monitor symptoms and the process of cancer care, remain in regular contact with the patient and communicate with the oncology team at least every 4 weeks The psychiatrist and case manager are available for consultation across care settings (outpatient, inpatient, home). Recommendations are documented in the medical record and communicated directly to the oncology team

Primary Outcomes

Measure
Feasibility of implementing the intervention in patients with SMI and cancer
time frame: 12 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness
Principal investigator Kelly Irwin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.