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NCT Number: NCT02594696

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.

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Key information

Conditions

Major Depression Bipolar Disorder Bipolar and Related Disorders Breast Cancer Breast Diseases Breast Neoplasms Cancer Depressive Disorder Depressive Disorder, Major Digestive System Diseases Digestive System Neoplasms GI Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Mental Disorders Mood Disorders Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

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

    Time frame: 12 weeks

    Study acceptability will be evaluated via exit interviews with oncology clinicians and study participants regarding the content, timing, and usefulness of the intervention.

  2. Rates of receipt of stage-appropriate cancer treatment

    Time frame: 6 Months

    Rates of receipt of stage-appropriate cancer treatment measured by medical record review and feedback from oncology clinician at 6 months post intervention

  3. Rates of receipt of healthcare utilization in the outpatient setting

    Time frame: 6 Months

    Rates of healthcare utilization in outpatient setting measured by medical record review at 6 months post intervention

  4. Rates of receipt of healthcare utilization in the acute care setting

    Time frame: 6 Months

    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

  5. Change in clinician-rated psychiatric symptoms

    Time frame: Baseline to 12 weeks post intervention

    • Psychiatric symptom severity according to the Behavioral Psychiatric Rating Scale (BPRS) pre and 12 weeks post intervention

  6. Change in clinician-rated psychiatric illness severity

    Time frame: Baseline to 12 weeks post intervention

    • Psychiatric illness severity according to the Clinical Global Impression-Severity (CGI-S) scale pre-intervention, 4 weeks post intervention, and 12 weeks post intervention

  7. Change in self-reported psychiatric symptoms

    Time frame: Baseline to 12 weeks post intervention

    • Self reported psychiatric symptoms according to the Behavior and Symptoms Identification Scale (BASIS) pre, 4 weeks post intervention, and 12 weeks post intervention

  8. Change in self-reported depression symptoms

    Time frame: Baseline to 12 weeks post intervention

    • Self-reported severity of depression according to the Patient Health Questionnaire-9 (PHQ-9) pre, 4 weeks post-intervention, and 12 weeks post-intervention

  9. Change in quality of life

    Time frame: Baseline to 12 weeks post intervention

    -Quality of life according to the Functional Assessment of Cancer Therapy-General (FACT-G)pre, 4 weeks post intervention, and 12 weeks post intervention

  10. Change in illness understanding

    Time frame: Baseline to 12 weeks post intervention

    Self-reported illness understanding according to the Prognosis and Treatment Perceptions Questionnaire at baseline and 12 weeks post intervention

  11. Change in alliance with the oncology clinician

    Time frame: Baseline to 12 weeks post intervention

    Self-reported alliance with the oncology clinician according to the Human Connection Scale at baseline and 12 weeks post intervention

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 3, 2015
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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