Clinical trial NCT06035731: Evaluation of the Medical Service by Socio-aesthetics in Oncology
Official title: Evaluation of the Medical Service by Socio-aesthetics in Oncology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Colon
Cancer, Lung
Cancer, Breast
Cancer Prostate
Cancer Pain
Anxiety Depression
Keywords: SOCIO-AESTHETIC
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label, randomized, controlled, multicenter intervention study
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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

Eligibility criteria: 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,

Primary outcomes:
measure: Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
timeFrame: up to 12 weeks
Secondary outcomes:
measure: pain EVA
timeFrame: up to 12 weeks
measure: Anxiety
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: AP HP
city: Tours
country: France
facility: Chru Tours
Study officials:
affiliation: CH VALENCE
name: Guillaume Guillaume
role: PRINCIPAL_INVESTIGATOR
References: