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| ID | Type | Description | Link |
|---|---|---|---|
| R37CA300110 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The proposed project is an implementation-effectiveness randomized trial of a person-centered collaborative care model for patients with serious mental illness and new cancer. The BRIDGE NET intervention is theoretically informed, pragmatic, and delivered virtually by an interdisciplinary team and includes early psychiatry consultation, integrated oncology and mental health treatment planning and regular patient outreach to adddress barriers to care. The BRIDGE NET intervention addresses the unique needs of patients with mental illness and cancer. To increase the reach of specialty cancer and mental health care, there is a critical need for interventions that can be delivered virtually. This work has can inform the standard of care for patients with serious mental illness and cancer and lay the groundwork for future multi--site trials.
This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE NET intervention. The proposed project addresses multiple modifiable disparities in cancer treatment and outcomes for a marginalized population of adults with SMI, who experience inequities in cancer treatment. The BRIDGE NET intervention is theoretically informed, pragmatic, and able to be delivered virtually by a diverse clinical team. Informed by qualitative interviews with clinicians and collaboration with a community advisory board, the investigators rigorously developed, piloted and tested the BRIDGE NET intervention and tailored the approach to the unique needs of patients with SMI and cancer. To increase the reach of specialty care and the limited mental health workforce, there is a critical need for interventions that can be delivered virtually. This work has potential to be foundational for future multi-site trials across national community oncology research networks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIDGE NET Intervention Arm | Active Comparator | BRIDGE NET is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers. |
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| Enhanced Usual Care Arm | No Intervention | EUC includes proactive identification of patients with SMI and a new cancer diagnosis, sending a templated email to the oncologist describing the patient's primary psychiatric diagnosis (e.g. schizophrenia, bipolar disorder, or major depression), and informing the patient of psychosocial services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIDGE NET | Other | BRIDGE is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers. Modules include Evaluation, Treatment Planning, Weekly Outreach, Biweekly Outreach, and Transition Planning. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Care Disruption | Primary outcome is the proportion of patients who experience clinically relevant disruptions (at least one delay to cancer treatment initiation, deviation from stage-appropriate cancer treatment, or interruption in planned treatment) within 24 weeks of study enrollment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to cancer treatment initiation | Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation). | Up to 24 weeks |
| Depression (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Irwin, MD, MPH | Contact | 617-726-2000 | kirwin1@mgb.org |
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If the results of this research study are published in a medical journal, they will not identify individual patients in the interest of protecting patient privacy and confidentiality.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE-NET intervention which combines features of a Phase II and Phase III trial given analysis of intervention outcomes and implementation outcomes.
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The PHQ-9 (Patient Health Questionnaire-9) is a standardized, 9-item self-report tool used by healthcare providers to screen for, diagnose, and measure the severity of depression. Higher score indicates more severe depression symptoms (minimum 0, maxiumum 27).
| Baseline, 6 weeks, 12 weeks, 24 weeks |
| Anxiety (GAD-7) | The GAD-7 (Generalized Anxiety Disorder-7) is a brief 7-item questionnaire used by healthcare providers to screen for Generalized Anxiety Disorder and measure the severity of anxiety symptoms. Higher scores indicate higher anxiety symptoms. (Minimum score 0, Maximum score 21). | Baseline, 6 weeks, 12 weeks, 24 weeks |