Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure (COSMIK)
12. januar 2021 opdateret af: Centre Jean Perrin
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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Clermont-Ferrand, Frankrig, 63011
- Centre Jean Perrin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Use of cosmetics during chemotherapy and thermal cure
Use of cosmetics during chemotherapy and post-treatment thermal cure
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"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Tidsramme: 6 months
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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.
Tidsramme: 6 months
|
The compliance will be measured by questions asking if patients stopped the use of cosmetics.
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6 months
|
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Percentage of patients declaring skin problems after the use of these 2 cosmetics
Tidsramme: 6 months
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Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
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6 months
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Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
Tidsramme: 6 months
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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
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6 months
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Patient expectations related to the use of cosmetics during chemotherapy
Tidsramme: 6 months
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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
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6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
Tidsramme: 1 year
|
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
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1 year
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Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped
Tidsramme: 1 year
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The compliance will be measured by questions asking if patients stopped the use of cosmetics
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1 year
|
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Percentage of patients declaring skin problems after the use of these 2 cosmetics
Tidsramme: 1 year
|
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
Tidsramme: 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
|
1 year
|
|
Patient expectations related to the use of cosmetics during post-treatment thermal cure
Tidsramme: 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
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Xavier DURANDO, Centre Jean Perrin
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2018
Primær færdiggørelse (Faktiske)
26. november 2020
Studieafslutning (Faktiske)
30. november 2020
Datoer for studieregistrering
Først indsendt
11. juli 2018
Først indsendt, der opfyldte QC-kriterier
24. september 2018
Først opslået (Faktiske)
25. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-004938-28
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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