A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.
详细描述
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-up after completion of acute phase of treatment for invasive breast cancer
排除标准
- •History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer
- •Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib
研究组 & 干预措施
On-demand personalized follow-up care
On-demand personalized follow-up care (on-demand access to a Wellness Beyond Cancer Program (WBCP) nurse and an annual follow-up by telephone with WBCP nurse following the patient's annual mammogram). Both groups of participants will have yearly mammograms (current standard of care) organized by their healthcare provider.
干预措施: On-demand personalized follow-up care (Other)
Guideline-based follow-up care
Guideline-based follow-up care (i.e. current standard of care). Both groups will have yearly mammograms (current standard of care) organized by their healthcare provider.
干预措施: Guideline-based follow-up care (standard of care) (Other)
结局指标
主要结局
Health-Related Quality of Life
时间窗: 24 months after randomization
Health-Related Quality of Life as determined by the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire designed to measure four domains of Health related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being.
次要结局
- Fear of recurrence(24 months after randomization)
- Anxiety levels(24 months after randomization)
- Treatment related toxicity concerns(24 months after randomization)
- Recurrence-free survival(24 months after randomization)
- Cost-effectiveness(24 months after randomization)
- Patient visits(24 months after randomization)