Cognitive ImpairmentNCT06662474
Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches
A study testing 1. cognitive stimulation and 2. psychoeducation and cognitive stimulation in people with Cognitive Impairment and Chemobrain, run by Grigore T. Popa University of Medicine and Pharmacy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cognitive Impairment, Chemobrain
- What is being tested?
- 1. cognitive stimulation and 2. psychoeducation and cognitive stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Simona Ruxandra Volovat, MD contact
About this study
Official title: Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy
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.
Read more
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
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Chemobrain
- Being tested
- 1. cognitive stimulation, 2. psychoeducation and cognitive stimulation, 3. no intervention
- Keywords
- breast cancer, cognitive impairment, quality of life, intervention
- Medical subject headings
- Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. cognitive stimulationOther
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 stimulationOther
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 interventionOther
maintaines their lifestyle up until their inclusion in the study without following additional measures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 1. cognitive stimulation |
| 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). Receives: Other: 2. psychoeducation and cognitive stimulation |
| 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 Receives: Other: 3. no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of cognitive decline in breast cancer patients receiving systemic treatments
using objective tests
Measured: before initiating interventions
rate of cognitive decline delay among those who implement prophylactic measures
using objective tests
Measured: from the moment the intervention was initiated until 6 months after the intervention
Secondary outcomes (3)
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.
Measured: from the moment the intervention was initiated until 6 months after the intervention
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.
Measured: 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.
Measured: from the moment the intervention was initiated until 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Ioana Boboc, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662474
- Sponsor's protocol ID
- 445/28.05.2024
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy
- ClinicalTrials.gov ID
- NCT06662474
- Acronym / sponsor ID
- 445/28.05.2024
- Conditions
- Cognitive Impairment, Chemobrain
- Keywords
- breast cancer, cognitive impairment, quality of life, intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| cognitive stimulation arm | Active comparator | Other: 1. cognitive stimulationwill 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 |
| psychoeducation and cognitive stimulation arm | Active comparator | Other: 2. psychoeducation and cognitive stimulationwill 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 | Other: 3. no interventionis considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. cognitive stimulationsudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks | Other | cognitive stimulation arm |
| 2. psychoeducation and cognitive stimulationsudoku, 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) | Other | psychoeducation and cognitive stimulation arm |
| 3. no interventionmaintaines their lifestyle up until their inclusion in the study without following additional measures | Other | placebo |
Primary outcome
presence of cognitive decline in breast cancer patients receiving systemic treatments
Time frame: before initiating interventions
using objective tests
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
3 secondary outcomes
quality of life
Time frame: from the moment the intervention was initiated until 6 months after the intervention
psycho-emotional status - state of coping assessment
Time frame: from the moment the intervention was initiated until 6 months after the intervention
psycho-emotional status - assessment of disturbance
Time frame: from the moment the intervention was initiated until 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona Ruxandra Volovat, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing 1. cognitive stimulation and 2. psychoeducation and cognitive stimulation in people with Cognitive Impairment and Chemobrain, run by Grigore T. Popa University of Medicine and Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DIANA IOANA BOBOC, MD (+40740882640, dianaiboboc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of cognitive decline in breast cancer patients receiving systemic treatments (time frame: before initiating interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.