Evaluation of the Medical Service by Socio-aesthetics in Oncology
NCT ID: NCT06035731
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-05-15
2027-04-30
Brief Summary
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The primary objective is to show that socio-aesthetics well being care improves quality of life during cancer treatment, compared to self care administration of dermo-cosmetics products
The secondary objectives are to show that socio-aesthetics well being care significantly reduced anxiety and pain compared to self care administration of dermo-cosmetics products
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Detailed Description
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this well-being care is imperfectly assessed with few data from randomized controlled trials.
The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon and lung cancer.
Patients will be randomly assigned to one of the two arms of the study according to a 1:1 ratio:
* Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive chemotherapy administrations .
* Group B (control) will apply the same dermo-cosmetics products themselves (self-care) without intervention of socio-aesthetic, during 4 consecutive chemotherapy administrations
12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure N°5:
* Pain assessed by Eva
* Anxiety assessed by HADS
* impact of socio-aesthetics care care , assessed by Patient Centricity Questionnaire (PCQ) (0 -110)
Data will be recorded using an e-CRF. patient will be recruited over 3 years and will be followed up for 3 months.
Hypothesis:
Socio-aesthetics session significantly improves quality of life and reduced pain and anxiety compared to self care administration of dermo-cosmetics products
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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group A: well-being care performed by SOCIO-AESTHETICS
Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetics, during 4 consecutive chemotherapy administrations.
Patients included will have following interventions :
quality of life: PCQ Pain: EVA Anxiety: HADS
SOCIO-AESTHETICS care
SOCIO-AESTHETICS well being care performed by qualify person
group B: control
Group B (control) will apply the dermo-cosmetic products themselves (self-care) without intervention of the socio-aesthetician, during 4 consecutive chemotherapy administrations.
quality of life: PCQ Pain: EVA Anxiety: HADS
No interventions assigned to this group
Interventions
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SOCIO-AESTHETICS care
SOCIO-AESTHETICS well being care performed by qualify person
Eligibility Criteria
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Inclusion Criteria
* treated with chemotherapy for lung , breast, colon or prostate cancer
* Able to understand, read, and write French,
* Affiliated with a social security scheme,
* Having dated and signed an informed consent.
Exclusion Criteria
* Deprived of their liberty by court or administrative decision,
18 Years
ALL
No
Sponsors
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Centre Hospitalier de Valence
OTHER
Responsible Party
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Principal Investigators
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Guillaume Guillaume
Role: PRINCIPAL_INVESTIGATOR
CH VALENCE
Locations
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Centre Antoine Lacassagne
Nice, , France
AP HP
Paris, , France
Chru Tours
Tours, , France
Countries
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Central Contacts
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Other Identifiers
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RIPH-CHV-13
Identifier Type: -
Identifier Source: org_study_id
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