Online cognitive exercises with supervision for breast cancer patients after chemotherapy
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial
This study is testing whether online brain exercises with help from a neuropsychologist can better reduce memory and thinking problems in breast cancer patients after chemotherapy compared to doing the exercises on their own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Months and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 25 sites (Bordeaux and 24 other locations) |
| Trial ID | NCT06027632 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a remotely supervised online cognitive stimulation program for patients with localized breast cancer who have undergone chemotherapy. Participants will be randomly assigned to either a supervised group, receiving guidance from a neuropsychologist, or a control group with unsupervised access to the same cognitive exercises. The aim is to assess whether the added supervision enhances the reduction of cognitive complaints associated with chemotherapy. The study also seeks to measure the impact of this intervention on objective cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older diagnosed with localized breast cancer who have received chemotherapy and report cognitive complaints affecting their quality of life.
Not a fit: Patients who do not report significant cognitive complaints or those who have not undergone chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for breast cancer survivors experiencing cognitive difficulties post-chemotherapy.
How similar studies have performed: Previous studies have shown the effectiveness of online cognitive stimulation programs, suggesting that this approach may yield positive results, although the specific aspect of remote supervision is less tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux and 24 other locations
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Not_yet_recruiting)
- Centre hospitalier de Bligny — Briis-sous-Forges, France (Recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- CH Métropole Savoie — Chambéry, France (Recruiting)
- Centre Jean Perrin — Clermont-Ferrand, France (Not_yet_recruiting)
- Centre George François Leclerc — Dijon, France (Not_yet_recruiting)
- Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France (Recruiting)
- CHU de Limoges — Limoges, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut Paoli Calmettes — Marseille, France (Recruiting)
- ICM Val d'Aurelle — Montpellier, France (Recruiting)
- Institut de Cancérologie de Lorraine — Nancy, France (Not_yet_recruiting)
- Hôpital privé du Confluent — Nantes, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
- Clinique Haute Energie — Nice, France (Not_yet_recruiting)
- CHU de Nimes — Nîmes, France (Recruiting)
- Hôpital Saint-Louis — Paris, France (Not_yet_recruiting)
- La Pitié Salpétrière — Paris, France (Not_yet_recruiting)
- Centre hospitalier de Pau — Pau, France (Recruiting)
- Centre Arrmoricain d'Oncologie — Plérin, France (Not_yet_recruiting)
- Centre Eugène Marquis — Rennes, France (Recruiting)
- Centre Henri Becquerel — Rouen, France (Recruiting)
- Clinique Mathilde — Rouen, France (Recruiting)
- Clinique Medico-chirurgicale Charcot — Sainte-Foy-lès-Lyon, France (Not_yet_recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.