Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

Chemotherapy Effect Clinical Trial

— PASITHEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649852
• Other study ID #: 2022-A01822-41
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Louis DOUBLET, MD
• Phone: 4 75 75 87 93
• Email: l.doublet[@]ramsaygds.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé Drôme Ardèche	Valence

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)