Clinical trial NCT06662474: Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches
Official title: Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Chemobrain
Keywords: breast cancer
cognitive impairment
quality of life
intervention
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a prospective, multi-arm study at determining the cognitive impairment decline rate after 12 weeks of different interventions for each study group .
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* female patients aged 18 years or older
* histologically confirmed treated invasive non-metastatic HR positive
* provided written informed consent
* (ECOG) performance status 0 -2
* adequate hematologic functions
* the patients must have completed the treatment (surgery or chemotherapy) for a minimum of 6 months and a maximum of 3 years before enrolling in the study
* patients who received chemotherapy for at least 3 months, including both dose-dense regimens and those administered every 3 weeks, as part of their disease treatment.
* patients are considered eligible for study continuation if, in 1 month of screening procedures, the tests to identify depression and severe anxiety do not indicate a severe status for them.

Exclusion Criteria:

* history of neoplasia other than breast cancer
* brain metastases
* acute neurological diseases, neuro-degenerative or major psychiatric conditions such as stroke, autism, ADHD, Alzheimer's disease, Parkinson's disease, dementia, obsessive-compulsive disorder, post-traumatic stress disorder, schizophrenia, and those with a history of craniocerebral trauma
* associated pathologies who may receive any form of treatment
* the administration of psychotropic or pain medications in the II and III categories
* (ECOG) ≧3
* laboratory tests that contraindicate the administration of active oncological treatment

Primary outcomes:
measure: presence of cognitive decline in breast cancer patients receiving systemic treatments
timeFrame: before initiating interventions
measure: rate of cognitive decline delay among those who implement prophylactic measures
timeFrame: from the moment the intervention was initiated until 6 months after the intervention
Secondary outcomes:
measure: quality of life
timeFrame: from the moment the intervention was initiated until 6 months after the intervention
measure: psycho-emotional status - state of coping assessment
timeFrame: from the moment the intervention was initiated until 6 months after the intervention
measure: psycho-emotional status - assessment of disturbance
timeFrame: from the moment the intervention was initiated until 6 months after the intervention
Other outcomes:
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