Evaluation of the Medical Service by Socio-aesthetics in Oncology

Last updated: August 27, 2025
Sponsor: Centre Hospitalier de Valence
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Cancer Pain

Prostate Cancer

Treatment

SOCIO-AESTHETICS care

Clinical Study ID

NCT06035731
RIPH-CHV-13
  • Ages > 18
  • All Genders

Study Summary

the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being care on quality of life, pain and anxiety.

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • over 18 years old

  • 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

Exclusion Criteria:

  • Unable to be followed for medical, social, family, geographic or psychologicalreasons for the duration of the study,

  • Deprived of their liberty by court or administrative decision,

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: SOCIO-AESTHETICS care
Phase:
Study Start date:
May 15, 2024
Estimated Completion Date:
April 30, 2027

Study Description

Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a physical, psychological and/or social attack.

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

Connect with a study center

  • Centre Antoine Lacassagne

    Nice,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice 2990440,
    France

    Active - Recruiting

  • AP HP

    Paris,
    France

    Site Not Available

  • AP HP

    Paris 2988507,
    France

    Active - Recruiting

  • Chru Tours

    Tours,
    France

    Site Not Available

  • Chru Tours

    Tours 2972191,
    France

    Active - Recruiting

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