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临床试验/NCT05523063
NCT05523063撤回不适用

Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in Quality of life questionnaire score

研究概览

简要总结

Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute.

Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer.

Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan.

However, it seems to be insufficiently proposed and prescribed in France at present.

CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse.

According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment."

Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life.

Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment.

With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival.

The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients.

They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI.

The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients aged 18 years or older at inclusion,
  • With breast cancer (diagnosis of breast cancer proven by anatomopathological evidence; all stages of the disease accepted), including recurrences,
  • Followed at the Croix-Rousse Hospital and managed by the CAMI for less than 3 months,
  • Provision of an informed information and collection of non-opposition.

排除标准

  • Patients who do not speak French,
  • Persons of legal age who are the subject of a legal protection measure,
  • Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care,
  • Pregnant or parturient women.

结局指标

主要结局

Change in Quality of life questionnaire score

时间窗: Change from Baseline Score of the Quality of life at 3 months

Difference between the quality of life questionnaire score calculated at baseline (first visit at CAMI) and after 3 months of follow-up by CAMI. The minimum and maximum values of the Quality of life questionnaire are respectively 0 (bad quality of life) and 100 (good quality of life).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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