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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06035731
Other study ID # RIHP-CHV-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


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
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