Patient-Centered, Team-Based Continuing Care After Breast Cancer Treatment: The ConnectedCancerCare Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
研究概览
简要总结
This study is an NCI-funded, randomized control pilot trial to evaluate: (1) the feasibility and acceptability of a web-based, personalized navigation tool (ConnectedCancerCare) and (2) explore whether the tool improves delivery of team-based survivorship care for women who have recently finished primary breast cancer treatment.
详细描述
This study is a randomized control pilot trial involving 60 women newly diagnosed with early-stage breast cancer who are finishing primary treatment. Participants will be randomized either to the intervention arm (CCC website that provides information on team-based follow-up care for both cancer surveillance and preventive care) or the control arm (static online survivorship care plan template, adapted from the ASCO breast cancer survivorship template). The feasibility and acceptability of the tool and correlations with patient-reported outcomes will be assessed 3 months following the completion of a baseline survey via an online follow-up survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized to the intervention (website) or control (informational template) after completing an online questionnaire; they will not be informed of which arm of the study they are participating. The allocation of participants will be masked for the investigator and outcomes assessor.
入排标准
- 年龄范围
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early Stage (0-IIB) breast cancer
- •Must be a patient of a University of Michigan Breast Cancer Oncologist
- •Must be completing primary cancer treatment and transitioning into survivorship
- •Must be able to speak, read and write in English
- •Must have access and the ability to use the internet
排除标准
- •Diagnosed with stage III or IV breast cancer
- •Unable to speak, read, and write in English
结局指标
主要结局
Number of Breast Cancer Patients Successfully Recruited to Participate in the Study
时间窗: At baseline survey
We anticipate a response rate of 80% enrollment (n=60). We will assess the number of patients successfully recruited who enroll and complete the baseline survey.
次要结局
- Percentage of Patients That Communicated With PCP About Provider Roles(3 months)
- Percentage of Patients Reporting a Preference for an Oncologist vs. PCP for Their Continuing Cancer Care Services(3 months)
- Patient-Reported Satisfaction With Oncologist/PCP Coordination of Care(3 months)
- Percentage of Patients Scheduling a Primary Care Physician (PCP) Appointment(3 months)
- Rating the Experience With the CCC Web-based, Survivorship Care Plan(Follow-Up Survey: 3 months)
- Knowledge About Team-based Survivorship Care(3 months)