NCT05690828

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

January 10, 2023

Last Update Submit

August 11, 2025

Conditions

Breast Cancer

Keywords

Cognition

Outcome Measures

Primary Outcomes (1)

  • Number of participants with improved quality of life (Emotional and functional QoL)

    Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in both the Emotional Well-Being (EWB) and Functional Well-Being (FWB) subscales of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).

    4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method

Secondary Outcomes (2)

  • Number of participants with improved quality of life (physical QoL)

    4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method

  • Number of participants with improved quality of life (Social/family QoL)

    4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method

Study Arms (2)

Group 1 (Cognitive remediation)

EXPERIMENTAL
Behavioral: Cognitive remediation

Group 2 (No cognitive remediation)

NO INTERVENTION

Interventions

Cognitive remediationBEHAVIORAL

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.

Group 1 (Cognitive remediation)

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20 to 60 years inclusive.
  • Informed consent dated and signed.
  • Patient with French social security cover in accordance with French law on biomedical research (Article 1121-11 of the French code of public health).

You may not qualify if:

  • Metastatic breast cancer.
  • Presence of unstable psychiatric or neurological disorders likely to affect cognition (information requested directly from the participant)
  • History of drug abuse.
  • Patient who cannot read or understand French.
  • Patient already included in this study.
  • Patient having participated in onCOGITE workshops.
  • Patient participating in another clinical trial evaluating cognitive remediation.
  • Patient deprived of freedom or subject to legal protection measures (under guardianship, in custody of the court, or family-member guardianship order).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Véronique GERAT-MULLER, PhD

    v.gerat-muller@bordeaux.unicancer.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

February 1, 2023

Primary Completion

October 30, 2024

Study Completion

March 31, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)