Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGrigore T. Popa University of Medicine and Pharmacy
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female patients aged 18 years or older
histologically confirmed treated invasive non-metastatic HR positive
provided written informed consent
(ECOG) performance status 0 -2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
1. cognitive stimulation
Other interventionsudoku, 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 interventionsudoku, 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 interventionmaintaines their lifestyle up until their inclusion in the study without following additional measures
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: cognitive stimulation armActive comparator 1 intervention
Group B: psychoeducation and cognitive stimulation armActive comparator 1 intervention
Group C: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
presence of cognitive decline in breast cancer patients receiving systemic treatments
using objective tests
Time frame
before initiating interventions2
rate of cognitive decline delay among those who implement prophylactic measures
using objective tests
Time frame
from the moment the intervention was initiated until 6 months after the interventionSecondary outcomes
1
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.
Time frame
from the moment the intervention was initiated until 6 months after the intervention2
psycho-emotional status - state of coping assessment
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.
Time frame
from the moment the intervention was initiated until 6 months after the intervention3
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.
Time frame
from the moment the intervention was initiated until 6 months after the interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: