Actively Recruiting
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2026-01-15
192
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of socio-aesthetic care on anxiety levels in cancer patients undergoing chemotherapy. The study focuses on patients receiving chemotherapy every 14 or 21 days for cancers such as lung, breast, digestive, colorectal, or gynecological types. The main purpose is to compare patients' "State Anxiety" scores before treatment and after the third chemotherapy cycle. Participants will be divided into two groups: one group will receive three sessions of socio-aesthetic care during their first chemotherapy administration, provided by a socio-esthetician. The other group will receive supportive care available at the center, including psychology consultations, sophrology, art therapy, physiotherapy, and hypnosis, but will not have socio-aesthetic care. Patients will be seen six times: at inclusion, during the first four chemotherapy courses, and at the end of chemotherapy. During the study, patients will complete anxiety questionnaires to measure their anxiety levels at various points. Researchers will assess changes in the "State Anxiety" score from the start of treatment through the third chemotherapy cycle, which lasts up to 21 days per cycle. Safety and adherence will be monitored throughout the chemotherapy period, with the total participation duration covering the chemotherapy cycles and follow-up visits.
CONDITIONS
Brief Title
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles
- Chemotherapy naive patient
- Patient speaking and understanding French and able to complete the questionnaires
- Patient having been informed and having signed an informed consent form to participate in the study
You will not qualify if you...
- Patient who has already benefited from socio-aesthetic care
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision)
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.)
- Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial
- Patient not benefiting from a social security scheme
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during consultation with oncologist before chemotherapy or at hospitalization
Duration - Duration of first 4 chemotherapy courses (approximately 6 to 12 weeks depending on cycle length)
Participants receive adjuvant chemotherapy every 14 or 21 days and may receive socio-aesthetic care or supportive care during chemotherapy cycles.
6 visits: inclusion, first four chemotherapy courses, and end of chemotherapy
Trial Site Locations
Total: 1 location
1
Hôpital Privé Drôme Ardèche
Valence, France, 26000
Actively Recruiting
Research Team
L
Louis DOUBLET, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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