Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

NCT05649852 | Recruiting

• 1 other identifier: 2022-A01822-41
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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)

Conditions

Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Chemotherapy

OTHER

Adjuvant chemotherapy treatment

Other: Socio-aesthetic care; Other: Supportive care

Interventions

Supportive care OTHER

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.

Chemotherapy

Socio-aesthetic care OTHER

Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy.

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Drôme Ardèche

Valence, 26000, France

RECRUITING

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Louis DOUBLET, MD

CONTACT

4 75 75 87 93; l.doublet@ramsaygds.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 14, 2022
• Study Start: March 23, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)