Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

Not Applicable

Recruiting

• Conditions: Chemotherapy Effect
• Interventions: Other: Socio-aesthetic care; Other: Supportive care

• Registration Number: NCT05649852
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

Detailed Description

As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.

The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.

Two cohorts of patients will be included:

* Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;

* Patients treated with chemotherapy every 14 days for digestive or other cancer.

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-03-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
• Chemotherapy naïve 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Supportive care	Adjuvant chemotherapy treatment
Chemotherapy	Socio-aesthetic care	Adjuvant chemotherapy treatment

Primary Outcome Measures

Name	Time	Method
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety	Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)	Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

Trial Locations

Locations (1)

Hôpital Privé Drôme Ardèche; 🇫🇷 Valence, France