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

Not Applicable

Completed

• Conditions: Local Breast Cancer Patients
• Interventions: Other: Cosmetics

• Registration Number: NCT03684135
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study Start: 2018-08-03
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Woman,
• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of cosmetics during chemotherapy and thermal cure	Cosmetics	Use of cosmetics during chemotherapy and post-treatment thermal cure

Primary Outcome Measures

Name	Time	Method
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.	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	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	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	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).	6 months	The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).

Secondary Outcome Measures

Name	Time	Method
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	The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
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	The compliance will be measured by questions asking if patients stopped the use of cosmetics
Percentage of patients declaring skin problems after the use of these 2 cosmetics	1 year	Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good	1 year	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
Patient expectations related to the use of cosmetics during post-treatment thermal cure	1 year	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

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France