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| Name | Class |
|---|---|
| UNICANCER | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remotely-supervised online cognitive stimulation intervention | Other |
| |
| Open access to online home-based cognitive exercises without supervision | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive exercises with supervision | Other | The experimental group will receive a 12-week intervention consisting of three 20-minute online cognitive stimulation sessions per week along with a weekly 30-minute centralized online remote supervision session with a neuropsychologist. Patient will also have access to the "PRESCO" program of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) | Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints) | After 12 weeks |
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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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine | Not yet recruiting | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41231878 | Derived | Bousquet M, Lange M, Lequesne J, Durand-Zaleski I, Diaz O, Di Meglio A, Bachelot T, Grellard JM, Clarisse B, Joly F. 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. PLoS One. 2025 Nov 13;20(11):e0335124. doi: 10.1371/journal.pone.0335124. eCollection 2025. |
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|
| Cognitive exercises without supervision | Other | Patient will have access to the program named "PRESCO" of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed |
|
| Centre hospitalier de Bligny | Recruiting | Briis-sous-Forges | France |
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| Centre François Baclesse | Recruiting | Caen | 14000 | France |
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| CH Métropole Savoie | Recruiting | Chambéry | France |
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| Centre Jean Perrin | Not yet recruiting | Clermont-Ferrand | France |
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| Centre George François Leclerc | Not yet recruiting | Dijon | France |
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| Groupe Hospitalier Mutualiste de Grenoble | Recruiting | Grenoble | France |
|
| CHU de Limoges | Recruiting | Limoges | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Institut Paoli Calmettes | Recruiting | Marseille | France |
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| ICM Val d'Aurelle | Recruiting | Montpellier | France |
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| Institut de Cancérologie de Lorraine | Not yet recruiting | Nancy | France |
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| Hôpital privé du Confluent | Recruiting | Nantes | France |
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| Centre Antoine Lacassagne | Recruiting | Nice | France |
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| Clinique Haute Energie | Not yet recruiting | Nice | France |
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| CHU de Nimes | Recruiting | Nîmes | France |
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| Hôpital Saint-Louis | Not yet recruiting | Paris | France |
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| La Pitié Salpétrière | Not yet recruiting | Paris | France |
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| Centre hospitalier de Pau | Recruiting | Pau | France |
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| Centre Arrmoricain d'Oncologie | Not yet recruiting | Plérin | France |
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| Centre Eugène Marquis | Recruiting | Rennes | France |
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| Centre Henri Becquerel | Recruiting | Rouen | France |
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| Clinique Mathilde | Recruiting | Rouen | France |
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| Clinique Medico-chirurgicale Charcot | Not yet recruiting | Sainte-Foy-lès-Lyon | France |
|
| Gustave Roussy | Recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
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