Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

NRG Oncology

Status: Enrolling

Conditions: Breast Cancer; Cognitive Impairments

Treatments: Behavioral: Arm 2: Computerized Cognitive Training-Neuroplasticity Games; Behavioral: Arm 1: Computerized Cognitive Training-Global Stimulation Games

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05896189

R01 1R01 CA276222-0 (Other Grant/Funding Number)

NCI-2023-06537 (Registry Identifier)

NRG-CC011

UG1CA189867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Full description

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Enrollment: 386 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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386 participants in 2 patient groups

Arm 1: Computerized Cognitive Training-Global Stimulation Games

Active Comparator group

Description:

The global stimulation games active attention control intervention is composed of computerized games. These games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 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.

Treatment:

Behavioral: Arm 1: Computerized Cognitive Training-Global Stimulation Games

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Experimental group

Description:

The neuroplasticity games provide core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight of these exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

Treatment:

Behavioral: Arm 2: Computerized Cognitive Training-Neuroplasticity Games