Breast Cancer Clinical Trial

The Engaging Primary Care in Cancer Survivorship (EPICS) Study

Summary

A quasi-experimental non-randomized pre/post with control group trial of two models of cancer survivorship care in early-stage colorectal and breast cancer survivors cared for in a community-based, integrated health care setting.

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Full Description

A quasi-experimental non-randomized pre/post with control group trial of two models of cancer survivorship care in early-stage colorectal and breast cancer survivors cared for in a community-based, integrated health care setting. The trial will test the efficacy of an embedded primary care provider (PCP) model (experimental condition) in which PCPs are embedded within an oncology practice and will care for low-risk survivors who will be transitioned at 6-36 months post-treatment for comprehensive survivorship care. We hypothesize that a) patients in the PCP model will have superior receipt of recommended care compared to usual care; b) patients in the PCP model will perceive significantly better care coordination, self-efficacy, and confidence in their PCP compared to usual care; and c) use of unplanned and non-recommended care will be less in the PCP model compared to usual care.

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Eligibility Criteria

Inclusion Criteria:

Patients: Adult (21+) Kaiser Permanente Southern California members diagnosed and treated for pathologically confirmed first primary early-stage breast (stage 0, I, II) or colorectal (stage I, II) cancer within Kaiser Permanente Southern California. Completed active cancer treatment within the past 6-36 months; active treatment includes cancer-directed surgery, chemotherapy (includes Herceptin (Trastuzumab)), radiation therapy, and ovarian suppression therapy (e.g., Goserelin (Zoladex)). Completed at least one office visit within Kaiser Permanente Southern California medical oncology. At low-risk for cancer recurrence and treatment-related toxicities based on state of disease and treatment modalities. For our Aim 2 survey: Primary language of English or Spanish (although we will assess our Aim 1 participants for recorded preferred spoken language and adjust translations as needed). Ability to complete surveys of patient-reported outcomes.
Physicians: For centers assigned to the embedded primary care physician (PCP) model, PCPs selected to participate must be Board Certified in a relevant primary care specialty; hold a valid and current MD or advanced practitioner license; and be employed by the Southern California Permanente Medical Group.

Exclusion criteria:

Patients less than 21 years of age
Patients at high risk for recurrence and treatment-related toxicities based on stage of disease and treatment modalities

Study is for people with:

Breast Cancer

Estimated Enrollment:

2450

Study ID:

NCT04745754

Recruitment Status:

Enrolling by invitation

Sponsor:

Kaiser Permanente

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There are 13 Locations for this study

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Kaiser Permanente Orange County Anaheim/Irvine Medical Center Oncology Clinics
Anaheim California, 92806, United States
Kaiser Permanente Baldwin Park Medical Center Oncology Clinic
Baldwin Park California, 91706, United States
Kaiser Permanente Downey/Bellflower Medical Center Oncology Clinics
Downey California, 90242, United States
Kaiser Permanente Fontana Medical Center Oncology Clinic
Fontana California, 92335, United States
Kaiser Permanente South Bay Medical Center Oncology Clinic
Harbor City California, 90710, United States
Kaiser Permanente Kern County Medical Facilities Oncology Clinic
Kern California, 93306, United States
Kaiser Permanente Antelope Valley Medical Center Oncology Clinic
Lancaster California, 93534, United States
Kaiser Permanente Los Angeles Medical Center Oncology Clinic
Los Angeles California, 90027, United States
Kaiser Permanente West Lost Angeles Medical Center Oncology Clinic
Los Angeles California, 90034, United States
Kaiser Permanente Panorama City Medical Center Oncology Clinic
Panorama City California, 91402, United States
Kaiser Permanente Riverside/Palm Springs Medical Center Oncology Clinics
Riverside California, 92505, United States
Kaiser Permanente San Diego Medical Center Oncology Clinics
San Diego California, 92123, United States
Kaiser Permanente Woodland Hills Medical Center Oncology Clinic
Woodland Hills California, 91367, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2450

Study ID:

NCT04745754

Recruitment Status:

Enrolling by invitation

Sponsor:


Kaiser Permanente

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