Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)

Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)

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)

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Effect
• Intervention / Treatment: Other: Socio-aesthetic care; Other: Supportive care

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 Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis DOUBLET, MD; Phone Number: +33 4 75 75 87 93; Email: l.doublet@ramsaygds.fr

Study Locations

• France
  • Valence, France, 26000
    • Recruiting
    • Hopital Prive Drome Ardeche
    • Contact: Louis DOUBLET, MD; Phone Number: +33 4 75 75 87 93; Email: l.doublet@ramsaygds.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Chemotherapy; Adjuvant chemotherapy treatment

Other: Socio-aesthetic care; Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy.; Other: Supportive care; Group B (control) will not benefit of socio-aesthetic care during chemotherapy but will benefit all existing support care in the center and accessible to patients: psychology consultation, sophrology, art therapy, physiotherapy, hypnosis. The patient will receive support care (maximum 2) during the intercure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety	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)	Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: 2022-A01822-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No