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临床试验/NCT03684135
NCT03684135已完成不适用

Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure

Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.

研究概览

简要总结

The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during chemotherapy and post-treatment thermal cure

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > or = 18 years,
  • Performance status > or = 1 (according to WHO criteria),
  • Patient with histologically proven breast cancer, not metastasized,
  • Patient treated with neoadjuvant or adjuvant chemotherapy,
  • Absence of cutaneous lesions related to the pathology,
  • Patient fluent in the French language,
  • Patient affiliated to a social security scheme,
  • Obtaining written, signed and dated informed consent.

排除标准

  • Metastatic breast cancer,
  • Local relapse of breast cancer
  • History of cancer in the 5 years preceding the entry into the trial,
  • Patient already treated with chemotherapy,
  • Medical contraindications to the use of cosmetic products and the prescription of a spa treatment,
  • Patient deprived of liberty or under guardianship.

结局指标

主要结局

Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.

时间窗: 6 months

The compliance will be measured by questions asking if patients stopped the use of cosmetics.

Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good

时间窗: 6 months

The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products

Percentage of patients declaring skin problems after the use of these 2 cosmetics

时间窗: 6 months

Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.

Patient expectations related to the use of cosmetics during chemotherapy

时间窗: 6 months

Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption

Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).

时间窗: 6 months

The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).

次要结局

  • Mean satisfaction related to the use of cosmetics during post-treatment thermal cure using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).(1 year)
  • Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped(1 year)
  • Percentage of patients declaring skin problems after the use of these 2 cosmetics(1 year)
  • Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good(1 year)
  • Patient expectations related to the use of cosmetics during post-treatment thermal cure(1 year)

研究者

发起方
Centre Jean Perrin
申办方类型
Other
责任方
Sponsor

研究点 (2)

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