The EPICS (Engaging Primary Care in Cancer Survivorship) Study: A Trial of Novel Models of Care for Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,450
- 试验地点
- 26
- 主要终点
- Cancer surveillance care services
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Cancer surveillance care services
时间窗: 36 months
Receipt of guideline-recommended cancer surveillance care services.
Preventive care services
时间窗: 36 months
Receipt of guideline-recommended preventive care services.
次要结局
- Non-recommended surveillance care/non-planned emergency and urgent care services(36 months)
- Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44)(12 months)
- Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)(12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)(12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions Symptoms Scale (Self-efficacy for managing symptoms short form 8a (8 questions; 5-item Likert scale)(12 months)
- The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)(12 months)
- Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)(12 months)
- Primary Care Delivery of Survivorship Care Scale(12 months)
- Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)(12 months)
- The Satisfaction with Decision Scale(12 months)
- Confidence in Managing Survivorship Care(12 months)
- Cancer recurrence(12 months)
- Primary Care Delivery of Survivorship Care Scale(12 months)
- Non-recommended surveillance care/non-planned emergency and urgent care services(36 months)
- Medical Expenditure Panel Survey (MEPS) 2016, Experiences with Cancer Supplement, Section 7, Medical Care for Cancer Module (Item #44)(12 months)
- Patient-Centered Medical Home (PCMH) and Cancer Consumer Assessment of Healthcare Providers and Systems (CAHPS)(12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 (answer responses using a Likert Scale)(12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions Symptoms Scale (Self-efficacy for managing symptoms short form 8a (8 questions; 5-item Likert scale)(12 months)
- The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (version 3)(12 months)
- Receipt of Treatment Summary from Health Information and National Trends Survey (HINTS 4, Cycle 2)(12 months)
- Patient-Reported Bother from Side Effects of Cancer Therapy (Validated Single-Item Measure)(12 months)
- The Satisfaction with Decision Scale(12 months)
- Confidence in Managing Survivorship Care(12 months)
- Cancer recurrence(12 months)
研究者
Erin E. Hahn
Research Scientist I
Kaiser Permanente