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Completed

NCT Number: NCT06035731

Evaluation of the Medical Service by Socio-aesthetics in Oncology

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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 criteria

  • Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
  • Deprived of their liberty by court or administrative decision,

Treatment and study plan

SOCIO-AESTHETICS care

Other

SOCIO-AESTHETICS well being care performed by qualify person

Primary outcomes

  1. Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care

    Time frame: up to 12 weeks

    Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome

Secondary outcomes

  1. pain EVA

    Time frame: up to 12 weeks

    EVA (0-10) higher scores mean worse outcome.

  2. Anxiety

    Time frame: up to 12 weeks

    HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valence

Other

Registry information

Acronym: RCT-SE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Jun 11, 2026

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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