Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Socio-aesthetic care

    Other intervention

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

  • Supportive care

    Other intervention

    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.

Treatment groups

192 Participants
are divided into 1 treatment group
Group A: ChemotherapyOther 2 interventions

Trial outcomes

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)

Time frame
Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

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