Clinical trial NCT03684135: Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Official title: Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Breast Cancer Patients
Keywords: Breast cancer
Cosmetics
Satisfaction
Chemotherapy
Thermal cure
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
timeFrame: 6 months
measure: Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.
timeFrame: 6 months
measure: Percentage of patients declaring skin problems after the use of these 2 cosmetics
timeFrame: 6 months
measure: Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
timeFrame: 6 months
measure: Patient expectations related to the use of cosmetics during chemotherapy
timeFrame: 6 months
Secondary outcomes:
measure: 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).
timeFrame: 1 year
measure: Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped
timeFrame: 1 year
measure: Percentage of patients declaring skin problems after the use of these 2 cosmetics
timeFrame: 1 year
measure: Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
timeFrame: 1 year
measure: Patient expectations related to the use of cosmetics during post-treatment thermal cure
timeFrame: 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO
role: PRINCIPAL_INVESTIGATOR
References: