NCT06027632Recruiting
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment. The research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation/adherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 31 Aug 2023
- Start date
- 9 Feb 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Childhood cancers
- NCT number
- NCT06027632
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 9 Feb 2024 to the primary completion date, Jun 2028
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Personality disorder or any known progressive psychiatric pathology (e.g. schizophrenia),
Age
- 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)
Other
- Major visual and/or hearing deficit,
- 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.
Who the study is looking for
- 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:
- I have been upset about these problems;
- These problems have interfered with my ability to work;
- These problems have interfered with my ability to do things I enjoy;
- 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.
Age in the registry: 18 months to - · Sex: Female · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre hospitalier de Bligny Coordinator of this site? Confirm its status | Briis-sous-Forges | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CH Métropole-Savoie Coordinator of this site? Confirm its status | Chambéry | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| Centre George François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Groupe Hospitalier Mutualiste de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| ICM Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Institut de cancérologie de Lorraine Coordinator of this site? Confirm its status | Nancy | France | Not yet recruiting |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Clinique Haute Energie Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| La Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier de Pau Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| Centre Arrmoricain d'Oncologie Coordinator of this site? Confirm its status | Plérin | France | Not yet recruiting |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Clinique Mathilde Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Clinique Médico-chirurgicale CHARCOT Coordinator of this site? Confirm its status | Sainte-Foy-lès-Lyon | France | Not yet recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.