Enrollment on hold
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
NCT No.: NCT05896189
Study Type: INTERVENTIONAL
Phase:
n/a
Region: California - Northern
Acronym:
Official Title
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
Purpose
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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• 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 with greater than or equal to 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy.
• The participant must be able to understand, speak, read, and write in English or Spanish.
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Exclusion Criteria
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• 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.
• Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years.
• 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.
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Keywords and/or Specific Medical Conditions
Sponsors
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