Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chemotherapy Effect

Intervention / Treatment
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* Other: Socio-aesthetic care
* Other: Supportive care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemotherapy<br>Adjuvant chemotherapy treatment | Other: Socio-aesthetic care<br>* Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy.<br>Other: Supportive care<br>* 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.<br>|

What is the study measuring?
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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) |