Evaluation of the Medical Service by Socio-aesthetics in Oncology
RCT-SE
1 other identifier
interventional
400
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 8, 2025
August 1, 2025
2.5 years
August 29, 2023
September 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
pain EVA
up to 12 weeks
Anxiety
up to 12 weeks
Study Arms (2)
group A: well-being care performed by SOCIO-AESTHETICS
EXPERIMENTALGroup 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
group B: control
NO INTERVENTIONGroup 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
Interventions
SOCIO-AESTHETICS well being care performed by qualify person
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Centre Antoine Lacassagne
Nice, France
AP HP
Paris, France
Chru Tours
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Guillaume
CH VALENCE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 13, 2023
Study Start
May 15, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
September 8, 2025
Record last verified: 2025-08