Qualité de vie liée à la santé couplée à des informations thérapeutiques sur l'observance de l'hormonothérapie dans le cancer du sein (COMPLIANCE)

Essai clinique

Type : Académique
Statut : Ouvert
Phase : Étude observationnelle
Étape du traitement : Traitement néo adjuvant
Étape de prise en charge : Entretien
Date d'ouverture : 14/05/2021
Date clôture : 31/10/2025
Promoteur : Centre Georges Francois Leclerc
Progression du cancer: Loco-régional
Résumé :

Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

Domaines/spécialités :
  • Cancer du sein
Pathologies :
  • Tumeur maligne du sein - Cim10 : C50
Liens externes :

Critères de population

Sexe : Femme
Age minimum : 18 ans
Critères d’inclusion :
  • Women aged 18 and over
  • With non-metastatic hormone receptor positive breast cancer
  • Women will have to be at the end of primary treatment
  • An indication for endocrine therapy treatment during 5 to 10 years
  • be affiliated to a French social security scheme or beneficiary of such a scheme
  • agreed to participate by signing a written consent
Critères d’exclusion :
  • Participants who participate in another clinical trial where HRQoL is assessed
  • Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.).
  • Vulnerable participants (pregnant women, etc.)

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr DESMOULINS
Prénom : Isabelle
Téléphone : Non disponible
Email : idesmoulins@cgfl.fr
CONTACT TECHNIQUE
Nom : BOUZIGUES
Prénom : Sophie
Téléphone : 03 45 34 80 89
Email : sbouzigues@cgfl.fr

Référentiels Oncologik

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