Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Socio-aesthetic care, Supportive care.
- Who it may be relevant to
- Registry conditions: Chemotherapy Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
Overview
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
- Other Socio-aesthetic care
Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy. - Other 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.
Primary outcome measures
- Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety [Time frame: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Hôpital Privé Drôme Ardèche — Valence
Identifiers
NCT: NCT05649852 · 2022-A01822-41