Clinical trial NCT06027632: Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Official title: Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cognitive Dysfunction
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: UNICANCER
First posted: 2023-09-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
timeFrame: After 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Briis-sous-Forges
country: France
facility: Centre hospitalier de Bligny
city: Caen
country: France
facility: Centre François Baclesse
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre George François Leclerc
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nantes
country: France
facility: Hôpital privé du Confluent
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Clinique Haute Energie
city: Nimes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: La Pitié Salpétrière
city: Pau
country: France
facility: Centre hospitalier de Pau
city: Plérin
country: France
facility: Centre Arrmoricain d'Oncologie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: Clinique Mathilde
city: Sainte Foy Les Lyon
country: France
facility: Clinique Medico-chirurgicale Charcot
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: