Online Cognitive Stimulation with Remote Neuropsychologist Support to Improve Post-Chemotherapy Cognitive Difficulties in Women Treated for Localized Breast Cancer
Led by Centre Francois Baclesse · Updated on 2025-09-19
300
Participants Needed
25
Research Sites
39 weeks
Total Duration
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
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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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants complete a 12-week online cognitive stimulation program. This includes three 20-minute cognitive exercise sessions weekly, with or without weekly 30-minute remote supervision by a neuropsychologist depending on group assignment.
Weekly remote supervision visits for those in the supervised group; cognitive exercises done independently for the unsupervised group
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Remotely supervised online cognitive training to reduce cognitive difficulties following chemotherapy in patients treated for localized breast cancer: Protocol of the Cog-Stim2 multicenter randomized controlled trial.