Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors (NCT05896189) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
United States386 participantsStarted 2024-02-29
Plain-language summary
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Who can participate
Age range18 Years – 100 Years
SexALL
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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…