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临床试验/NCT04966819
NCT04966819招募中不适用

Assessing Current Survivorship Care Needs of Rectal Cancer Patients and Piloting a Dedicated Survivorship Initiative

Jewish General Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months

研究概览

简要总结

The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once we have realized measurable, successful implementation in this population, our hope is then to expand our initiative to all colon cancer patients.

详细描述

Rectal cancer is a life-altering diagnosis that can have long-lasting effects not only on one's physical health, but also their psychological, emotional and financial well-being. With advancements in both disease detection and therapeutic options, there is now a growing cohort of patients who have successfully completed active rectal cancer treatment and transitioned into post-treatment care. Unfortunately, the post-treatment phase has its own set of challenges. Lost in Transition was one of the first major publications to advocate for dedicated survivorship planning, raising awareness of the needs of cancer survivors. Since then, both the National Comprehensive Cancer Network (NCCN) and the American Cancer Society have released guidelines for survivorship care focused on prevention, surveillance, assessment, intervention, coordination of care and survivorship planning. Despite these efforts to bolster survivorship care, studies have found an average of 2.88 unmet needs among cancer survivors affecting physical, financial, educational, emotional and psychology domains. The investigators propose a multifaceted rectal cancer survivorship care program involving oncology specialists, nursing support and primary care physicians. This initiative centers on regular meetings with oncology nursing support, enhanced communication and coordination of care among clinicians including primary care physicians, and an educational platform for patients regarding the late and long-term effects of cancer. Initial efforts will target rectal cancer patients specifically as they have been identified as being at high risk of having unmet needs. Once the investigators have realized measurable, successful implementation in this population, the hope is then to expand this initiative to all colon cancer patients.

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
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, it is not possible to mask the participant nor the care provider. However, outcome assessor will be blinded to the treatment allocation when analyzing primary and secondary outcomes.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (>18 years-old)
  • rectal cancer patients who underwent curative intent treatment between 2019-2020 (i.e. in the last 2 years), including those who underwent surgical resection (abdominoperineal resection or restorative proctectomy with or without ileostomy) and those managed non-operatively, with chemoradiotherapy will be included.

排除标准

  • Cannot be contacted by telephone
  • Unable to read and comprehend English or French;
  • Unable to give clear and informed consent.

结局指标

主要结局

Short Form-Survivor Unmet Needs Survey (Unmet needs) at 12 months

时间窗: 12 months after study start

Score ranges from 0 to 4. Higher score means higher degree of unmet needs.

次要结局

  • National Comprehensive Cancer Network Distress Thermometer(Baseline, 3, 6, and 12 months after study start)
  • Short Form-Survivor Unmet Needs Survey (Unmet needs)(Baseline, 3, and 6 months after study start)
  • Global Quality of Life (QoL)(Baseline, 3, 6, and 12 months after study start)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Marylise Boutros

Associate Professor

Jewish General Hospital

研究点 (2)

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