Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Breast Cancer; Head and Neck Cancer; Schizophrenia; Lung Cancer; Bipolar Disorder; Major Depression; GI Cancer
• Intervention / Treatment: Other: Proactive Psychiatry Consultation (PPC)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Proactive Psychiatry Consultation (PPC); 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention for patients with SMI and cancer and oncology clinicians	Study acceptability will be evaluated via exit interviews with oncology clinicians and study participants regarding the content, timing, and usefulness of the intervention.	12 weeks
Rates of receipt of stage-appropriate cancer treatment	Rates of receipt of stage-appropriate cancer treatment measured by medical record review and feedback from oncology clinician at 6 months post intervention	6 Months
Rates of receipt of healthcare utilization in the outpatient setting	Rates of healthcare utilization in outpatient setting measured by medical record review at 6 months post intervention	6 Months
Rates of receipt of healthcare utilization in the acute care setting	Rates of healthcare utilization in acute care setting (aggregate measure of emergency visits and hospitalizations) measured by medical record review at 6 months post intervention	6 Months
Change in clinician-rated psychiatric symptoms	- Psychiatric symptom severity according to the Behavioral Psychiatric Rating Scale (BPRS) pre and 12 weeks post intervention	Baseline to 12 weeks post intervention
Change in clinician-rated psychiatric illness severity	- Psychiatric illness severity according to the Clinical Global Impression-Severity (CGI-S) scale pre-intervention, 4 weeks post intervention, and 12 weeks post intervention	Baseline to 12 weeks post intervention
Change in self-reported psychiatric symptoms	- Self reported psychiatric symptoms according to the Behavior and Symptoms Identification Scale (BASIS) pre, 4 weeks post intervention, and 12 weeks post intervention	Baseline to 12 weeks post intervention
Change in self-reported depression symptoms	- Self-reported severity of depression according to the Patient Health Questionnaire-9 (PHQ-9) pre, 4 weeks post-intervention, and 12 weeks post-intervention	Baseline to 12 weeks post intervention
Change in quality of life	-Quality of life according to the Functional Assessment of Cancer Therapy-General (FACT-G)pre, 4 weeks post intervention, and 12 weeks post intervention	Baseline to 12 weeks post intervention
Change in illness understanding	Self-reported illness understanding according to the Prognosis and Treatment Perceptions Questionnaire at baseline and 12 weeks post intervention	Baseline to 12 weeks post intervention
Change in alliance with the oncology clinician	Self-reported alliance with the oncology clinician according to the Human Connection Scale at baseline and 12 weeks post intervention	Baseline to 12 weeks post intervention

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); American Cancer Society, Inc.
• Investigators: Principal Investigator: Kelly Irwin, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2015
• Primary Completion (Actual): July 21, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia; Breast Cancer; Lung Cancer; Bipolar disorder; GI cancer; Head and Neck cancer; Schizophrenia and Cancer; Major depression and Cancer; Bipolar disorder and Cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Neoplasms; Neoplasms by Site; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Depression; Head and Neck Neoplasms; Schizophrenia; Mental Disorders; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 15-293; 5R25CA092203-13 (U.S. NIH Grant/Contract)