Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches

NCT06662474 | Not Yet Recruiting

• 1 other identifier: 445/28.05.2024
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Cognitive Impairment; Chemobrain

Keywords

breast cancer; cognitive impairment; quality of life; intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• quality of life

  from the moment the intervention was initiated until 6 months after the intervention

• psycho-emotional status - state of coping assessment

  from the moment the intervention was initiated until 6 months after the intervention

• psycho-emotional status - assessment of disturbance

  from the moment the intervention was initiated until 6 months after the intervention

Study Arms (3)

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

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).

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

Other: 3. no intervention

Interventions

1. cognitive stimulation OTHER

sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks

cognitive stimulation arm

2. psychoeducation and cognitive stimulation OTHER

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)

psychoeducation and cognitive stimulation arm

3. no intervention OTHER

maintaines their lifestyle up until their inclusion in the study without following additional measures

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment; Breast Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

DIANA IOANA BOBOC, MD

CONTACT

+40740882640; dianaiboboc@gmail.com

Simona Ruxandra Volovat, MD

CONTACT

simonavolovat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, PhD Student, Investigator in Clinical Trials

Model Details: 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 .

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10