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Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

Primary Purpose

Major Depression, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Psychiatry Consultation (PPC)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depression focused on measuring Major depression and Cancer, Schizophrenia and Cancer, Bipolar disorder and Cancer, Lung Cancer, Breast Cancer, Head and Neck cancer, GI cancer, Schizophrenia, Bipolar disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proactive Psychiatry Consultation (PPC)

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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
Change in clinician-rated psychiatric symptoms
- Psychiatric symptom severity according to the Behavioral Psychiatric Rating Scale (BPRS) pre and 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
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
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
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
Change in illness understanding
Self-reported illness understanding according to the Prognosis and Treatment Perceptions Questionnaire at baseline and 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

Full Information

First Posted
October 29, 2015
Last Updated
February 2, 2018
Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc., National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02594696
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
July 21, 2016 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc., National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Irwin, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

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