Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Chemobrain
• Intervention / Treatment: Other: 1. cognitive stimulation; Other: 2. psychoeducation and cognitive stimulation; Other: 3. no intervention

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DIANA IOANA BOBOC, MD; Phone Number: +40740882640; Email: dianaiboboc@gmail.com
• Study Contact Backup: Name: Simona Ruxandra Volovat, MD; Email: simonavolovat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cognitive stimulation arm; 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	Other: 1. cognitive stimulation; sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks
Active Comparator: psychoeducation and cognitive stimulation arm; 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).	Other: 2. psychoeducation and cognitive stimulation; 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 Comparator: placebo; is considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures	Other: 3. no intervention; maintaines their lifestyle up until their inclusion in the study without following additional measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 - 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
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.	from the moment the intervention was initiated until 6 months after the intervention

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; intervention; cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 445/28.05.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No