Breast Cancer
Conditions
Keywords
Chemotherapy-induced cognitive impairment, Neuropsychological assessments, Breast cancer, Adjuvant chemotherapy, Neo-adjuvant chemotherapy
Brief summary
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
Detailed description
This interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting CRCI in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy. A total of 128 patients will be randomized 1:1 into two groups: * Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed. * Control group, which will only carry out neuropsychological assessments. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Interventions
OTHERNeurotablet® and Neuropsychological evaluations
The experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signature of informed consent * Diagnosis of operable/operated breast cancer * Patients candidate to be treated with Neo/adjuvant chemotherapy
Exclusion criteria
* Previous chemotherapy treatments * Patients with Metastatic breast cancer * Patients affected by pathologies of the brain, head trauma, and intellectual disabilities * Patients affected by previous or current neurological and/or psychiatric disorders * Patients currently treated with psychopharmacological drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of a 10-week cognitive rehabilitation program | Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started) | Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of cognitive function trends in the control group | Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started) | Analysis of cognitive function trends though neurocognitive evaluations |
Contacts
Primary ContactOrnella Garrone, MD
Outcome results
None listed