Evaluation of the Medical Service by Socio-aesthetics in Oncology

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Evaluation of the Medical Service by Socio-aesthetics in Oncology

Conditions
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Cancer of Colon, Cancer, Lung, Cancer, Breast, Cancer Prostate, Cancer Pain, Anxiety Depression

Intervention / Treatment
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* Other: SOCIO-AESTHETICS care


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label, randomized, controlled, multicenter intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A: well-being care performed by SOCIO-AESTHETICS<br>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 | Other: SOCIO-AESTHETICS care<br>* SOCIO-AESTHETICS well being care performed by qualify person<br>|
| No Intervention: group B: control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care | Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain EVA | EVA (0-10) higher scores mean worse outcome. | up to 12 weeks | 
| Anxiety | HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SOCIO-AESTHETIC