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

Centre Hospitalier de Valence

Status: Enrolling

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

Treatments: Other: SOCIO-AESTHETICS care

Study type: Interventional

Funder types: Other

Identifiers

NCT06035731

RIPH-CHV-13

Details and patient eligibility

About

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

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

group A: well-being care performed by SOCIO-AESTHETICS

Experimental group

Description:

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

Treatment:

Other: SOCIO-AESTHETICS care

group B: control

No Intervention group

Description:

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