Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT06027632
Eligibility Criteria:
Inclusion Criteria:
* Patient diagnosed with localized breast cancer
* Age 18 or older,
* Who have received adjuvant or neo-adjuvant chemotherapy and are currently undergoing adjuvant radiotherapy (ongoing hormone therapy, maintenance therapy other as target therapies or immunotherapy are permitted) until 6 months after end of radiotherapy.
* Patients who report cognitive complaints that significantly impact their quality of life, as evaluated by the quality of life subscale of the FACT-Cog questionnaire. This subscale is composed by 4 questions:
1. I have been upset about these problems;
2. These problems have interfered with my ability to work;
3. These problems have interfered with my ability to do things I enjoy;
4. These problems have interfered with the quality of my life.
Patients are eligible if their score on this subscale is at or below the 10th percentile, based on age guidelines and normative data (Lange et al., 2015), namely:
* ≤ 8 for patients aged 30-49 years
* ≤ 9 for patients aged 50-69 years
* ≤ 10 for patients aged 70-89 years
* Patients who have completed at least three years of primary school education, as determined by the Barbizet scale,
* Patient with access to a functional laptop/computer with a keyboard, internet connection and an e-mail account - being able to use those tools alone,
* Fluent in French,
* Patients who have provided informed consent to participate in the study.
Exclusion Criteria:
* Personality disorder or any known progressive psychiatric pathology (e.g. schizophrenia),
* Previous neurological history with ongoing cognitive symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),
* Excessive alcohol intake or drug use, which could compromise participation to the intervention
* Major visual and/or hearing deficit,
* Patient who might not be able to complete neuropsychological testing, (including those with significant cognitive disorders that impede the completion of cognition tests, as determined by the cognitive screening test MoCA (MONTREAL COGNITIVE ASSESSMENT) and based on age and educational level according to GRECOGVASC (Reflection Group for Vascular COGnitive Assessment) normative data)
* Already participating in a cognitive training program,
* Refusal to participate,
* Patient deprived of liberty or under guardianship,
* Patient who might not be able to participate due to geographic, social or psychopathological reasons.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Months
Study:
NCT06027632
Study Brief:
Protocol Section:
NCT06027632