Back to resultsSatisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure (COSMIK)
Primary Purpose
Local Breast Cancer Patients
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cosmetics
Sponsored by
About this trial
This is an interventional supportive care trial for Local Breast Cancer Patients focused on measuring Breast cancer, Cosmetics, Satisfaction, Chemotherapy, 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.
Sites / Locations
- Centre Jean Perrin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of cosmetics during chemotherapy and thermal cure
Arm Description
Use of cosmetics during chemotherapy and post-treatment thermal cure
Outcomes
Primary Outcome Measures
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).
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.
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.
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
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
Secondary Outcome Measures
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).
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
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03684135
Brief Title
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Acronym
COSMIK
Official Title
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
November 26, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Breast Cancer Patients
Keywords
Breast cancer, Cosmetics, Satisfaction, Chemotherapy, Thermal cure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of cosmetics during chemotherapy and thermal cure
Arm Type
Experimental
Arm Description
Use of cosmetics during chemotherapy and post-treatment thermal cure
Intervention Type
Other
Intervention Name(s)
Cosmetics
Intervention Description
"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource
Primary Outcome Measure Information:
Title
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Description
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Time Frame
6 months
Title
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.
Description
The compliance will be measured by questions asking if patients stopped the use of cosmetics.
Time Frame
6 months
Title
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Description
Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Time Frame
6 months
Title
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
Description
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
Time Frame
6 months
Title
Patient expectations related to the use of cosmetics during chemotherapy
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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).
Description
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Time Frame
1 year
Title
Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped
Description
The compliance will be measured by questions asking if patients stopped the use of cosmetics
Time Frame
1 year
Title
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Description
Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Time Frame
1 year
Title
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
Description
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
Time Frame
1 year
Title
Patient expectations related to the use of cosmetics during post-treatment thermal cure
Description
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
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
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