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Completed

NCT Number: NCT03684135

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

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

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Key information

Conditions

Local Breast Cancer Patients Behavior Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Personal Satisfaction Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cosmetics

Other

"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Acronym: COSMIK

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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