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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:
Depending on the group in which the patient was randomly assigned, the interventions are :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive stimulation arm | Active Comparator | 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 |
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| psychoeducation and cognitive stimulation arm | Active Comparator | 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). |
|
| placebo | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| presence of cognitive decline in breast cancer patients receiving systemic treatments | using objective tests | before initiating interventions |
| rate of cognitive decline delay among those who implement prophylactic measures | using objective tests | from the moment the intervention was initiated until 6 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | 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. | from the moment the intervention was initiated until 6 months after the intervention |
| psycho-emotional status - state of coping assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DIANA IOANA BOBOC, MD | Contact | +40740882640 | dianaiboboc@gmail.com | |
| Simona Ruxandra Volovat, MD | Contact | simonavolovat@gmail.com |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
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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 .
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| 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 |
|
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. |
| from the moment the intervention was initiated until 6 months after the intervention |
| psycho-emotional status - assessment of disturbance | 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. | from the moment the intervention was initiated until 6 months after the intervention |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |