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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08CA230185-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard Risk Management Foundation | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.
It is challenging to cope with cancer. The investigators want to understand if it is helpful for patients with serious mental illness (SMI) to be connected to a psychiatrist and case manager when cancer is diagnosed. Many people with illnesses like major depression, schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to appointments, have many different doctors, and experience depression or worry. Better communication between the patient, the oncology team, and mental health providers may improve care. As for all patients, it is important for people with mental illness to have access to high quality cancer treatment that is patient-centered and coordinated. Having a case manager and psychiatrist at the cancer center who collaborates with the oncology team starting at cancer diagnosis may help patients to receive the cancer care that they need.
This study includes a single-arm open pilot (n=8) to pilot patient and caregiver measures and refine the intervention manual; a run-in period (n=6) to pilot the randomized trial procedures; and a randomized controlled trial (n=120) to compare the impact of the Bridge model with enhanced usual care on disruptions in cancer care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive Psychiatry Consultation (PPC) - PILOT | Experimental | Proactive Psychiatry Consultation and Case Management is:
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| Proactive Psychiatry Consultation (PPC) - Randomized Trial | Experimental | Proactive Psychiatry Consultation and Case Management is:
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| Enhanced Usual Care (EUC) - Randomized Trial | Active Comparator | Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Psychiatry Consultation (PPC) | Other | Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need. |
| Measure | Description | Time Frame |
|---|---|---|
| Disruptions in Cancer Care | The number of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment). | 6 months from study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| BPRS (24) | Brief Psychiatric Rating Scale (BPRS) 24 24-item instrument where the rater enters a number for each symptom. Each symptom construct is rated on a Likert scale from 1 (NOT PRESENT) - 7 (EXTREMELY SEVERE). The sum of all 24 items is then calculated to a maximum score of 168 (24X7=168). The minimum score is 24 and the maximum score is 168. The higher the score, the more psychiatrically impaired the patient is. Higher scores mean worse psychiatric symptoms. |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Participants
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| Name | Affiliation | Role |
|---|---|---|
| Kelly E Irwin, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36307008 | Derived | Irwin KE, Callaway CA, Corveleyn AE, Pappano CR, Barry MJ, Tiersma KM, Nelson ZE, Fields LE, Pirl WF, Greer JA, Temel JS, Ryan DP, Nierenberg AA, Park ER. Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer. Contemp Clin Trials. 2022 Dec;123:106975. doi: 10.1016/j.cct.2022.106975. Epub 2022 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care (EUC) - Randomized Trial | Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 30, 2021 |
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1. A consensus panel of disease-specific oncologists who are blinded to intervention arm will review all patients at 24 weeks of care and evaluate for disruptions in cancer care.
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| Enhanced Usual Care (EUC) | Other | At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services. |
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| Week 0, Week 12, Week 24 |
| PHQ-9 | Patient Health Questionnaire-9 is a 9-item instrument that measures patient depression where a score of 1-4 indicates minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression. The minimum score is 1 and the maximum score is 27. | Week 0, Week 6, Week 12, Week 24 |
| FG001 | Proactive Psychiatry Consultation (PPC) - Randomized Trial | Proactive Psychiatry Consultation and Case Management is:
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need. |
| FG002 | Enhanced Usual Care (EUC) - Randomized Trial: CAREGIVERS | Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial. |
| FG003 | Proactive Psychiatry Consultation (PPC) - Randomized Trial: CAREGIVERS | Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics data were collected from patients and caregivers
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care (EUC) - Randomized Trial | Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services. |
| BG001 | Proactive Psychiatry Consultation (PPC) - Randomized Trial | Proactive Psychiatry Consultation and Case Management is:
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need. |
| BG002 | Enhanced Usual Care (EUC) - Randomized Trial - CAREGIVERS | Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial. |
| BG003 | Proactive Psychiatry Consultation (PPC) - Randomized Trial - CAREGIVERS | Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data collected for patients ONLY. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Caregiver Enrolled | Data collected for patients ONLY. | Count of Participants | Participants |
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| Cancer Diagnosis | Cancer diagnosis data collected for patients ONLY. | Count of Participants | Participants |
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| Severe Mental Illness Diagnosis | SMI data collected for patients ONLY. | Count of Participants | Participants |
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| Psychiatrist | Data point collected for patients ONLY. | Count of Participants | Participants |
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| Relationship to Patient | Relationship of caregiver to patient. | Data point collected for caregivers ONLY. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disruptions in Cancer Care | The number of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment). | Posted | Count of Participants | Participants | 6 months from study enrollment |
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| Secondary | BPRS (24) | Brief Psychiatric Rating Scale (BPRS) 24 24-item instrument where the rater enters a number for each symptom. Each symptom construct is rated on a Likert scale from 1 (NOT PRESENT) - 7 (EXTREMELY SEVERE). The sum of all 24 items is then calculated to a maximum score of 168 (24X7=168). The minimum score is 24 and the maximum score is 168. The higher the score, the more psychiatrically impaired the patient is. Higher scores mean worse psychiatric symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 12, Week 24 |
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| Secondary | PHQ-9 | Patient Health Questionnaire-9 is a 9-item instrument that measures patient depression where a score of 1-4 indicates minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression. The minimum score is 1 and the maximum score is 27. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, Week 12, Week 24 |
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The specific duration of time over which each participant was assessed is equal to an average of 24 weeks.
Adverse Event data was not collected for caregivers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care (EUC) - Randomized Trial | Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services. | 6 | 57 | 0 | 57 | 0 | 57 |
| EG001 | Proactive Psychiatry Consultation (PPC) - Randomized Trial | Proactive Psychiatry Consultation and Case Management is:
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need. | 4 | 58 | 0 | 58 | 0 | 58 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Irwin, MD, MPH | Massachusetts General Hospital | 617-643-4453 | kirwin1@partners.org |
| Nov 8, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003865 | Depressive Disorder, Major |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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