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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
RECRUITINGN/ASponsored by NRG Oncology
Actively Recruiting
PhaseN/A
SponsorNRG Oncology
Started2024-04-12
Est. completion2027-02-28
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations670 sites
View on ClinicalTrials.gov →
NCT05896189
Summary
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Eligibility
Age: 18 Years – 100 YearsHealthy volunteers accepted
Inclusion Criteria: * The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. * The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. * The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. * Participants must be at least 6 months and no more than 5 years (after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy). Participants may still be taking endocrine therapy and/or trastuzumab. * The participant must be able to understand, speak, read, and write in English or Spanish. Exclusion Criteria: * Scoring less than or equal to 3 on the 6-item cognitive screen. * Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. * Definitive clinical or radiologic evidence of metastatic disease. * Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible. * Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). * Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. * Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. * Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability. * Participants who are enrolled in an active behavioral intervention (e.g., occupational therapy, physical therapy, etc.) or pharmaceutical intervention or who are in the follow-up phase of a cancer control trial or therapeutic trial that has extensive PRO follow-up after treatment ends. Participants who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and/or survival analysis (cancer-related mortality or all-cause mortality) would be eligible. * Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.
Conditions3
Breast CancerCancerCognitive Impairments
Locations670 sites
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorNRG Oncology
Started2024-04-12
Est. completion2027-02-28
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations670 sites
View on ClinicalTrials.gov →
NCT05896189