Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1
研究概览
简要总结
This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.
详细描述
The investigators plan a single site prospective, randomized, trial that will compare the effect of REASSURE on survivor preparedness against usual care. Survivors will be identified from breast oncology clinics within UW Health.
REASSURE is comprised of three components: 1) the REASSURE PRO assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) REASSURE survivorship messaging.
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Primary Objective
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Compare survivors' preparedness for survivorship with REASSURE versus usual care.
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Secondary Objectives
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Determine the acceptability of REASSURE for survivors living in rural and non-rural areas.
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Assess changes in survivor reported symptoms and number of follow-up visits with REASSURE versus usual care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I, ER and/or PR positive, her2neu negative breast cancer within the last 6-24 monoths
- •Willing to complete study procedures using email
排除标准
- •Receipt of chemotherapy for the stage I ER and/or PR positive, her2neu negative breast cancer diagnosed within the last 6-24 months
- •Participants will be excluded if they are unable to read and write in English or if, in the opinion of a treating clinician, have cognitive impairment that would prevent completion of study procedures
- •Pregnancy, based on patient self-report. If a patient becomes pregnant during the study period, they will be removed from the study at that time.
- •Diagnosis of a ER and PR negative, her2neu negative breast cancer or a her2neu positive breast cancer within the last 5 years
研究组 & 干预措施
REASSURE Follow Up care
干预措施: REASSURE (Other)
Usual Follow Up Care
结局指标
主要结局
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1
时间窗: up to 18 months
Survivors' preparedness for survivorship will be assessed using Part 1 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is an 11-item survey scored on a 4 point likert scale for a total possible range of score from 11 - 44 where higher scores indicate increased preparedness.
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2
时间窗: up to 18 months
Survivors' confidence about follow-up will be assessed using Part 2 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is a 5-item survey scored on a 10 point likert scale for a total possible range of score from 5 - 50 where higher scores indicate increased confidence.
次要结局
- Number of Threshold-Level Symptoms Reported on the PRO Assessment(up to 18 months)
- Number of Follow Up Visits(up to 18 months)
- Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors(up to 18 months)
- Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit(up to 18 months)