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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684135
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

Study Description
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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

Condition or disease Intervention/treatment Phase
Local Breast Cancer Patients Other: Cosmetics Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Actual Study Start Date : August 3, 2018
Actual Primary Completion Date : November 26, 2020
Actual Study Completion Date : November 30, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied). [ Time Frame: 6 months ]
    The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).

  2. Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped. [ Time Frame: 6 months ]
    The compliance will be measured by questions asking if patients stopped the use of cosmetics.

  3. Percentage of patients declaring skin problems after the use of these 2 cosmetics [ Time Frame: 6 months ]
    Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.

  4. Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good [ Time Frame: 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

  5. Patient expectations related to the use of cosmetics during chemotherapy [ Time Frame: 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


Secondary Outcome Measures :
  1. 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). [ Time Frame: 1 year ]
    The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).

  2. Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped [ Time Frame: 1 year ]
    The compliance will be measured by questions asking if patients stopped the use of cosmetics

  3. Percentage of patients declaring skin problems after the use of these 2 cosmetics [ Time Frame: 1 year ]
    Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.

  4. Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good [ Time Frame: 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

  5. Patient expectations related to the use of cosmetics during post-treatment thermal cure [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684135


Locations
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France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
Investigators
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Principal Investigator: Xavier DURANDO Centre Jean Perrin
More Information
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT03684135    
Other Study ID Numbers: 2017-004938-28
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Jean Perrin:
Breast cancer
Cosmetics
Satisfaction
Chemotherapy
Thermal cure
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases