Evaluation of the Medical Service by Socio-aesthetics in Oncology

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06035731
Study type	Interventional
Source	Centre Hospitalier de Valence
Contact	Guillaume Guillaume
Phone	+33475752555
Email	gbuiret@ch-valence.fr
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	April 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of the Medical Service by Socio-aesthetics in Oncology — RCT-SE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms