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

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

Study Overview

• Status: Completed
• Conditions: Local Breast Cancer Patients
• Intervention / Treatment: Other: Cosmetics

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of cosmetics during chemotherapy and thermal cure; Use of cosmetics during chemotherapy and post-treatment thermal cure	Other: Cosmetics; "Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).	The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).	6 months
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.	The compliance will be measured by questions asking if patients stopped the use of cosmetics.	6 months
Percentage of patients declaring skin problems after the use of these 2 cosmetics	Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.	6 months
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good	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	6 months
Patient expectations related to the use of cosmetics during chemotherapy	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The mean satisfaction will be assessed 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	The compliance will be measured by questions asking if patients stopped the use of cosmetics	1 year
Percentage of patients declaring skin problems after the use of these 2 cosmetics	Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.	1 year
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good	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	1 year
Patient expectations related to the use of cosmetics during post-treatment thermal cure	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	1 year

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Xavier DURANDO, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Satisfaction; Breast cancer; Chemotherapy; Thermal cure; Cosmetics
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2017-004938-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No