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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Arm 1: Computerized Cognitive Training-Global Stimulation Games
BehavioralThe program will includes 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku. These games are well matched for time on task, novelty, and progression across levels. These are strategy-based games without adaptive, speeded, or accuracy-based algorithms underlying their personalization.
Arm 2: Computerized Cognitive Training-Neuroplasticity Games
BehavioralCognitive training exercises include Double Decision (targets visual speed of processing and useful field of view), Target Tracker (targets visuospatial working memory capacity), Visual Sweeps (targets speed of processing), Syllable Stacks (targets auditory memory), Eye for Detail (targets eye movement speed and visuo-spatial working memory), Mind Bender (targets mental flexibility), Divided Attention (a shape-color-pattern inhibitory control exercise that focuses on rapidly determining whether flashing colors, shapes, or patterns meet a pre-specified rule), Right Turn (targets spatial reasoning).
Treatment groups
386 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Computerized Cognitive Training-Global Stimulation GamesActive comparator 1 intervention
Group B: Arm 2: Computerized Cognitive Training-Neuroplasticity GamesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported perceived cognitive impairment measured-post intervention
FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
Time frame
12 weeks from randomizationSecondary outcomes
1
Self-reported perceived cognitive impairment measured over time
FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
Time frame
36 weeks from randomization2
Objectively measured cognitive performance measured over time
Processing speed score as measured by Telephone-Based Assessment of Neuropsychological Status (TBANS) Symbol Digit Modalities Test
Time frame
36 weeks from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov