Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

Официальное название

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

Обзор

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)

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety [Срок оценки: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital Privé Drôme Ardèche — Valence

Идентификаторы

NCT: NCT05649852 · 2022-A01822-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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