NCT06662474

Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The trial consists of identifying the presence of cognitive decline and following up on methods of preventing its accentuation through psychoeducation and cognitive stimulation. The trial includes longitudinal assessments of some subjective perception markers and objective assessments of cognitive decline. Furthermore, the study will delve into the dynamics of these markers, revealing alterations in the psycho-affective state. The study aims to assess the impact of interventions on the cognitive decline associated with cancer and its treatment, as well as the role they can play in improving breast cancer patients' quality of life.

Conditions

• Cognitive Impairment
• Chemobrain

Interventions

Type	Name	Description
OTHER	1. cognitive stimulation	sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks
OTHER	2. psychoeducation and cognitive stimulation	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)
OTHER	3. no intervention	maintaines their lifestyle up until their inclusion in the study without following additional measures

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2026-12-31
• First posted: 2024-10-29
• Last updated: 2024-10-30