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NCT Number: NCT06662474

Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

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

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Key information

Conditions

Cognitive Impairment Breast Diseases Breast Neoplasms Chemically-Induced Disorders Chemobrain Chemotherapy-Related Cognitive Impairment Cognition Disorders Cognitive Dysfunction Drug-Related Side Effects and Adverse Reactions Mental Disorders Neoplasms Neoplasms by Site Neurocognitive Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1. cognitive stimulation

Other

sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks

2. psychoeducation and cognitive stimulation

Other

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)

3. no intervention

Other

maintaines their lifestyle up until their inclusion in the study without following additional measures

Primary outcomes

  1. presence of cognitive decline in breast cancer patients receiving systemic treatments

    Time frame: before initiating interventions

    using objective tests

  2. rate of cognitive decline delay among those who implement prophylactic measures

    Time frame: from the moment the intervention was initiated until 6 months after the intervention

    using objective tests

Secondary outcomes

  1. quality of life

    Time frame: from the moment the intervention was initiated until 6 months after the intervention

    The EORTC quality of life questionnaire (QLQ) is used for assessing the quality of life of cancer patients. A higher score indicates higher quality of life, while a lower a decrease of it.

  2. psycho-emotional status - state of coping assessment

    Time frame: from the moment the intervention was initiated until 6 months after the intervention

    The investigators will be able to characterize the psycho-emotional status of the patients based on the scores obtained from evaluations using the Mental Adjustment Scale in Cancer. The scale (29 items) describes the state of coping that the patient has toward the disease The score is associated with the strength of behavior towards coping with cancer.

  3. psycho-emotional status - assessment of disturbance

    Time frame: from the moment the intervention was initiated until 6 months after the intervention

    The investigators will be characterize the psycho-emotional status using DASS-21 R scales. The DASS-21 evaluates the negative emotion that a patient recognizes, represented by stress, anxiety, and depression.

    The severity of the affected psycho-emotional status increases the DASS-21 R scale score proportionally. The test associates the minimum score with a normal psychological response and categorizes an increase in scores based on the intensity of the symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

DIANA IOANA BOBOC, MD

CONTACT

[email protected]

+40740882640

Simona Ruxandra Volovat, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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