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Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

NCT06662474 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-30

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-01
Completion
2026-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06662474 on ClinicalTrials.gov