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Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer

Study acronym: COG STIM 2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 12 of 25 sitesv7
  2. Study sites: 22 to 25
    • Eligibility criteria expanded, about 8 words
    v6
  3. Eligibility criteria revised
    • Site details revised at 22 of 22 sites
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Feb 9, 2024
    • Study sites: 16 to 22
    v4
  5. Interventions: Open access to online home-based cognitive exercises without supervision (Other), Remotely-supervised online cognitive stimulation… to Cognitive exercises with supervision (Other), Cognitive exercises without supervision (Other)
    • Eligibility criteria expanded, about 9 words
    v3
  6. Primary endpoint revisedv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06027632
Lead Sponsor Centre Francois Baclesse
Collaborators: UNICANCER
Conditions
(from sponsor)		 Breast Cancer, Cognitive Dysfunction
Related terms Breast Neoplasms, Cognitive Dysfunction
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov