Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNRG Oncology
About this trial
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Arm 1: Computerized Cognitive Training-Global Stimulation Games
- Arm 2: Computerized Cognitive Training-Neuroplasticity Games
Treatment groups
386 Participants
are divided into 2 treatment groupsSponsors and collaborators
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov