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

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Chemotherapy Effect

Treatments

Other: Supportive care
Other: Socio-aesthetic care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05649852
2022-A01822-41

Details and patient eligibility

About

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)

Full 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.

Enrollment

192 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

192 participants in 1 patient group

Chemotherapy
Other group
Description:
Adjuvant chemotherapy treatment
Treatment:
Other: Socio-aesthetic care
Other: Supportive care

Trial contacts and locations

1

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Central trial contact

Louis DOUBLET, MD

Data sourced from clinicaltrials.gov

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