Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

NCT02594696 | Completed

• 2 other identifiers: 15-2935R25CA092203-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing the intervention in patients with SMI and cancer

  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

  12 weeks

Secondary Outcomes (11)

• Acceptability of the intervention for patients with SMI and cancer and oncology clinicians

  12 weeks

• Rates of receipt of stage-appropriate cancer treatment

  6 Months

• Rates of receipt of healthcare utilization in the outpatient setting

  6 Months

• Rates of receipt of healthcare utilization in the acute care setting

  6 Months

• Change in clinician-rated psychiatric symptoms

  Baseline to 12 weeks post intervention

Study Arms (1)

Proactive Psychiatry Consultation (PPC)

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)

Other: Proactive Psychiatry Consultation (PPC)

Interventions

Proactive Psychiatry Consultation (PPC) OTHER

* 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

Proactive Psychiatry Consultation (PPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Schizophrenia; Bipolar Disorder; Lung Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Kelly Irwin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Harvard Medical School

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 3, 2015
• Study Start: November 9, 2015
• Primary Completion: July 21, 2016
• Study Completion: November 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (1)