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Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05649852
Acronym
PASITHEA
Enrollment
192
Registered
2022-12-14
Start date
2023-03-23
Completion date
2027-06-30
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effect

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.

Interventions

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

OTHERSupportive 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.

Sponsors

Euraxi Pharma
CollaboratorINDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of mean of the State Anxiety score of the State Trait Inventory AnxietyBetween 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)

Countries

France

Contacts

Primary ContactLouis DOUBLET, MD
l.doublet@ramsaygds.fr4 75 75 87 93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026