NCT05690828

Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.

Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This project will investigate the efficacy of a cognitive remediation programme in patients treated for breast cancer. patients will be randomized between "no intervention" and "intervention programme". Efficay will be assessed in term of improved quality of life.

Detailed description

Medical progress in the treatment of cancer has prolonged patients' life expectancy. This improvement has led researchers to become concerned about the long-term negative effects of cancer treatments on quality-of-life. In particular, previous studies have identified complaints that have been submitted concerning the cognitive status of patients treated with chemotherapy (Berglund et coll., 1991). All of these cognitive changes are collectively grouped under the term chemobrain. The consequences of treatments remain however underestimated, as the priority when diagnosing cancer remains the patient's short- to medium-term survival; yet, quality-of-life contributes to the long-term survival of patients (Kramer, 2000). In addition to medical treatments, psychosocial care adapted to the specific needs of subjects is thus important for improving their quality-of-life and helping them return to work. Even if initiatives have multiplied over the past few decades in the psychosocial management of these subjects (e.g., supportive care), that related to cognitive disorders in subjects having survived cancer remains a little documented field. Cognitive deficiency in cancer survivors is said to be moderate (Razaq et coll., 2017), which makes survivors ideal candidates for cognitive rehabilitation.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive remediation	The cognitive remediation programme shall be run either in video workshops or face to face workshops and in home sessions via a web app. The programme will run for 4 months during which there will be 3 different evaluations. A first evaluation after randomisation, a second evaluation 4 months after inclusion (corresponding to the end of the programme), and a third evaluation 8 months after inclusion for the experimental group (4 months after the end of the programme). The face to face workshops will take 8 to 10 participants and will be led by a neuropsychologist.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-10-30
• Completion: 2026-03-31
• First posted: 2023-01-19
• Last updated: 2025-08-13

Locations

1 site across 1 country: France