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NCT Number: NCT05690828

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 20 to 60 years inclusive.
  • Localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the last cycle of which took place between 2 and 24 months prior to inclusion.
  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Cognitive Remediation

Behavioral

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Number of participants with improved quality of life (physical QoL)

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

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

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

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

    Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in the Social/family subscale of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Association Oncogite
  • University of Bordeaux

Registry information

Official study title

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

Acronym: e-ONCOGITE

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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