Breast Cancere-ONCOGITENCT05690828
Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.
A study testing Cognitive remediation in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
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.
Read the 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
- Being tested
- Cognitive remediation
- Keywords
- Cognition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Cognitive remediation) | Experimental | Not described Receives: Behavioral: Cognitive remediation |
| Group 2 (No cognitive remediation) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Number of participants with improved quality of life (Social/family QoL)
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).
Measured: 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Oct 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux, Association Oncogite
- Responsible party
- Sponsor
- Investigators
- Véronique GERAT-MULLER, PhD, Principal investigator, v.gerat-muller@bordeaux.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690828
- Sponsor's protocol ID
- IB2022-04
- Acronym
- e-ONCOGITE
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
- ClinicalTrials.gov ID
- NCT05690828
- Acronym / sponsor ID
- e-ONCOGITE / IB2022-04
- Conditions
- Breast Cancer
- Keywords
- Cognition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- University of Bordeaux, Association Oncogite
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Cognitive remediation) | Experimental | Behavioral: Cognitive remediation |
| Group 2 (No cognitive remediation) | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediationThe 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. | Behavioural | Group 1 (Cognitive remediation) |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique GERAT-MULLER, PhD principal investigator
v.gerat-muller@bordeaux.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.