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临床试验/NCT03049124
NCT03049124撤回不适用

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

University of Ottawa2 个研究点 分布在 1 个国家开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Recruitment Rates

研究概览

简要总结

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered.

The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible.

The specific objectives are to:

  1. Test the feasibility and safety of a 12-week exercise intervention;
  2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes);
  3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Recruitment Rates

时间窗: Through study completion, an average of 12 weeks

The number of eligible participants who enrol in the study out of the number who are referred.

Retention Rates

时间窗: Through study completion, an average of 12 weeks

The number of participants completing the intervention and all scheduled assessments.

Adherence Rates

时间窗: Through study completion, an average of 12 weeks

The number of exercise sessions completed out of 36.

Number of Participants with Adverse Events

时间窗: Through study completion, an average of 12 weeks

The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.

次要结局

未报告次要终点

研究者

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

Jennifer Brunet

Assistant Professor

University of Ottawa

研究点 (2)

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