Breast Cancer Females, Oncology
Conditions
Keywords
Cognitive training, Cancer
Brief summary
Introduction: The significant improvement in breast cancer survival, largely attributable to biomedical and technological progress, makes it increasingly necessary to investigate the secondary effects linked to this pathology. Among these, cancer-related cognitive impairment (CRCI) stands out as one of the most frequent yet frequently overlooked complications. Objective: To evaluate the impact of a structured cognitive training program on the management of CRCI in patients with breast cancer receiving active treatment. Methodology: A randomized controlled clinical trial will be conducted with two arms: an Intervention Group (IG) and a Control Group (CG). The study will include patients with a recent diagnosis of breast cancer. Based on sample size calculations, 50 participants will be recruited-25 per group-to detect a minimum difference of 2.95 points on the MoCA (Montreal Cognitive Assessment), a tool commonly used to assess cognitive performance. All participants will receive an informational leaflet aligned with the latest WHO recommendations for preventing cognitive decline. In addition, the IG will complete an individualized cognitive training (CT) program focused on everyday cognitive skills (EC). The program will provide a dossier with 80 training sessions, structured into four phases (P1-P4) of 20 activities each, to be implemented monthly. Baseline assessments and a follow-up four months after the intervention will be carried out in both groups. Variables collected will include sociodemographic and clinical data, as well as outcome measures for cognitive status (MoCA), everyday cognition (PECC), anxiety levels (Hamilton scale), functional capacity (LB), sleep quality (PSQI), quality of life (ECOG), and subjective memory complaints (FACT-COG). Impact: Findings from this study could support the development of targeted cognitive rehabilitation strategies and the implementation of clinical protocols for individuals undergoing breast cancer treatment. By addressing CRCI-an underrecognized but increasingly prevalent issue given rising survival rates-these interventions may contribute to improving patients' overall quality of life.
Interventions
BEHAVIORALHealth Education Program
An informative leaflet will promote a healthy lifestyle with WHO guidelines to reduce cognitive decline, recommending a balanced diet, physical activity, social engagement, cognitive games, good sleep, stress management, hydration, and avoiding smoking and excessive alcohol.
BEHAVIORALIndividual Cognitive Training Program
The cognitive training program (CT) on everyday cognition (EC) will be individualized, with each participant receiving a tailored dossier. The intervention includes four 1-month training periods (P1-P4), each featuring 20 activities, conducted at a rate of 5 activities per week over 4 months.
BEHAVIORALGroup training program
The group cognitive training program (CT) on everyday cognition (EC) will be individualized, with each participant receiving a tailored dossier. The intervention includes four 1-month training periods (P1-P4), each featuring 20 activities, conducted at a rate of 5 activities per week over 4 months.
Sponsors
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Being an adult (18 years or older). Having a recent histopathological diagnosis of newly diagnosed breast cancer and starting oncological treatment. Being fully capable of performing daily functions. Willingness to voluntarily participate in the study and signing the informed consent.
Exclusion criteria
Lack of literacy skills or significant language comprehension deficit. Diagnosis of a Central Nervous System tumor or participation in another cognitive stimulation program. Clinical diagnosis of a neurocognitive disorder as defined in the DSM-V. Withdrawal Criteria: Dropping out of the program or not completing the final evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | Baseline; "4 months final" | The Montreal Cognitive Assessment Test (MoCA Test) Version 8.3. This test detects mild cognitive impairment (MCI) by assessing executive functions, attention, abstraction, memory, calculation, and orientation. It takes about 10 minutes to administer. The maximum score is 30 points, with scores below 26 indicating MCI |
| Subjective Perception of Cognitive Impairment in Cancer Patients | Baseline; "4 months final" | FACT-COG (Version 3) (24): This 37-item questionnaire is divided into six cognitive domains: memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. Additionally, it includes two subscales: "notability" (comments from others) and "perceived impact of cognitive impairment on quality of life." Respondents indicate the frequency of each occurrence over the past 7 days on a 5-point Likert scale, from 0 ("never") to 4 ("several times a day"). The scores from the individual subscales are summed to determine the total FACT-Cog score, ranging from 0 to 148, with higher scores indicating better cognitive functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Everyday Cognition | Baseline; "4 months final" | Test for the Evaluation of Everyday Cognition (PECC) (18): This test measures an individual's ability to solve 12 real-life situations in areas such as medication management, administrative tasks, financial management, meal preparation, transportation, and shopping, thus assessing functional capacity in daily life. The administration time is 35 minutes. |
| Anxiety | Baseline; "4 months final" | Hamilton Anxiety Rating Scale (19): A clinical assessment tool used to measure the level of anxiety experienced by a person. It consists of 14 items, each with five response options ranging from "not present" to "very severe." The final score can be 17 or less (mild anxiety), between 18 and 24 (moderate anxiety), and between 25 and 30 (severe anxiety). |
| Functionality | Baseline; "4 months final" | Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale (20): Designed to evaluate autonomy in instrumental activities in older adults. It takes about 4 minutes to administer, scoring each item as 0 or 1, with a total score of 8. |
| Sleep Quality | Baseline; "4 months final" | Pittsburgh Sleep Quality Index (PSQI) (21): Designed to measure sleep quality in individuals aged 24 to 83 years. It takes 5-10 minutes to administer. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. |
| Subjective Memory Failures | Baseline; "4 months final" | Everyday Memory Failures Questionnaire (23): It includes categories such as "talking, reading, and writing," "names and faces," "actions," and "learning new things." Responses are given on a 9-point Likert scale, ranging from "Not at all in the last 3 months" to "More than once a day." Due to the complexity of the nine options, some authors use fewer response options. |
Countries
Spain
Contacts
CONTACTJuan Luis Sánchez González, Phd
Outcome results
None listed