Major DepressionNCT02594696
Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness
A study testing Proactive Psychiatry Consultation (PPC) in people with Major Depression and Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression, Schizophrenia, Bipolar Disorder
- What is being tested?
- Proactive Psychiatry Consultation (PPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2015to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment severe enough to interfere with completing the study assessments or providing informed consent
- History of dementia or traumatic brain injury
- Refuse participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer
- Being tested
- Proactive Psychiatry Consultation (PPC)
- 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
- Medical subject headings
- Depressive Disorder, Major, Schizophrenia, Bipolar Disorder, Lung Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Proactive Psychiatry Consultation (PPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start9 Nov 2015
- Primary completion21 Jul 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kelly Edwards Irwin, Massachusetts General Hospital
- Investigators
- Kelly Irwin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594696
- Sponsor's protocol ID
- 15-293
- Other IDs
- 5R25CA092203-13
- Status last verified
- Feb 2018
- First submitted
- 29 Oct 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness
- ClinicalTrials.gov ID
- NCT02594696
- Acronym / sponsor ID
- 15-293
- Conditions
- Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer
- Keywords
- Major depression and Cancer, Schizophrenia and Cancer, Bipolar disorder and Cancer, Lung Cancer, Breast Cancer, Head and Neck cancer, GI cancer, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 21 Jul 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proactive Psychiatry Consultation (PPC) | Experimental | Other: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment severe enough to interfere with completing the study assessments or providing informed consent
- History of dementia or traumatic brain injury
- Refuse participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Proactive Psychiatry Consultation (PPC) |
Primary outcome
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
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Irwin, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Psychiatry Consultation (PPC) in people with Major Depression and Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing the intervention in patients with SMI and cancer (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.