Evaluation of the Medical Service by Socio-aesthetics in Oncology

Cancer Pain Clinical Trial

— RCT-SE  

Official title:

Evaluation of the Medical Service by Socio-aesthetics in Oncology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035731
• Other study ID #: RIHP-CHV-13
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2027

Study information

• Verified date: December 2023
• Source: Centre Hospitalier de Valence
• Contact: Guillaume Guillaume
• Phone: +33475752555
• Email: gbuiret[@]ch-valence.fr
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety Depression
• Breast Neoplasms
• Cancer of Colon
• Cancer Pain
• Cancer Prostate
• Cancer, Breast
• Cancer, Lung
• Colonic Neoplasms
• Lung Neoplasms

Intervention

Other:
• SOCIO-AESTHETICS care
SOCIO-AESTHETICS well being care performed by qualify person

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pain EVA	EVA (0-10) higher scores mean worse outcome.	up to 12 weeks
Secondary	Anxiety	HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.	up to 12 weeks