Actively Recruiting
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer a Multicenter Randomized Controlled Trial
Led by Centre Francois Baclesse · Updated on 2025-09-19
300
Participants Needed
25
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
U
UNICANCER
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a remotely supervised online cognitive stimulation program compared to an unsupervised online cognitive exercise program to reduce cognitive complaints in patients treated for localized breast cancer after adjuvant chemotherapy. This study aims to understand if supervision by a neuropsychologist improves the effectiveness of cognitive interventions. Prior studies showed benefits from online programs, and this research explores the added value of personalized support and education during the intervention. The trial includes two groups one receiving a 12-week program with three 20-minute online cognitive sessions weekly plus a 30-minute weekly remote supervision session by a neuropsychologist, and a control group with access to the same online cognitive exercises without supervision. The exercises target up to 12 cognitive areas such as attention, memory, executive functions, and processing speed using the PRESCO program from the HAPPYNeuron-Pro software. Participants will be monitored over 12 weeks, with researchers assessing changes in perceived cognitive impairment using the Functional Assessment of Cancer Therapy-Cognitive Function FACT-Cog questionnaire. The primary outcome is the average change in the Perceived Cognitive Impairment subscale after 12 weeks. The study also evaluates adherence to the program and benefits on objective cognitive impairment. The study is randomized and includes adult female patients who have received chemotherapy and are undergoing radiotherapy.
CONDITIONS
Brief Title
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with localized breast cancer
- Age 18 or older
- Received adjuvant or neo-adjuvant chemotherapy and currently undergoing adjuvant radiotherapy
- Ongoing hormone, maintenance, targeted, or immunotherapy allowed until 6 months after radiotherapy
- Significant cognitive complaints impacting quality of life, with FACT-Cog subscale score at or below age-based 10th percentile
- Completed at least three years of primary school education
- Access to and ability to use a functional laptop/computer with internet and email
- Fluent in French
- Provided informed consent to participate
You will not qualify if you...
- Personality disorder or progressive psychiatric diseases such as schizophrenia
- Previous neurological conditions with ongoing cognitive symptoms
- Excessive alcohol or drug use affecting participation
- Major visual or hearing impairment
- Unable to complete neuropsychological testing due to significant cognitive disorders
- Currently participating in another cognitive training program
- Refusal to participate
- Deprived of liberty or under guardianship
- Unable to participate due to geographic, social, or psychological reasons
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