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Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Secondary endpoints: details revised at 1 of 3 entriesv2
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators aim is to conduct a prospective study with three arms, involving non-metastatic breast cancer patients who underwent chemotherapy as part of their treatment and were on a form of hormone therapy at the time of study inclusion. The trial consists of identifying the presence of cognitive decline and following up on methods of preventing its accentuation. The goal of this clinical trial is to assess if psychoeducation and cognitive stimulation work to decrease the intensity of cognitive impairment. It aims to answer the following main questions: * The implementation of such interventions improves both the dysfunction quantified by objective tests but also the individual's perception of it. * The implementation changes the patients' quality of life. Researchers will compare three study groups, each with instructions to complete one of the related 12-week programs, to see if there are any changes. Depending on the group in which the patient was randomly assigned, the interventions are : * First group - will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks * the second group will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks and also hold open group meetings for psychoeducation (1 meeting every 2 weeks, 6 meetings in total). * Group 3 is considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures
Trial Details
NCT Number NCT06662474
Lead Sponsor Grigore T. Popa University of Medicine and Pharmacy
Conditions
(from sponsor)
Cognitive Impairment, Chemobrain
Related terms Breast Neoplasms, Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov