Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
Purpose
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Conditions
- Breast Cancer
- Cognitive Impairments
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm 1: Computerized Cognitive Training-Global Stimulation Games |
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. |
|
|
Experimental Arm 2: Computerized Cognitive Training-Neuroplasticity Games |
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. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
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Mechanicsville, Virginia 23116
Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
Richmond, Virginia 23226
Richmond, Virginia 23230
Richmond, Virginia 23235
Richmond, Virginia 23298
Roanoke, Virginia 24033
Site Public Contact
540-981-7377
South Hill, Virginia 23970
Winchester, Virginia 22601
Woodbridge, Virginia 22192
Aberdeen, Washington 98520
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Port Townsend, Washington 98368
Site Public Contact
360-344-3091
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Silverdale, Washington 98383
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Tacoma, Washington 98405
Walla Walla, Washington 99362
Huntington, West Virginia 25701
Appleton, Wisconsin 54911
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Site Public Contact
855-776-0015
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
Site Public Contact
218-568-4416
La Crosse, Wisconsin 54601
Site Public Contact
855-776-0015
Marshfield, Wisconsin 54449
Minocqua, Wisconsin 54548
Neenah, Wisconsin 54956
New Richmond, Wisconsin 54017
Oshkosh, Wisconsin 54904
Rice Lake, Wisconsin 54868
Shawano, Wisconsin 54166
Spooner, Wisconsin 54801
Stevens Point, Wisconsin 54482
Superior, Wisconsin 54880
Site Public Contact
701-364-6272
Waupaca, Wisconsin 54981
Weston, Wisconsin 54476
Bayamón, Puerto Rico 00959-5060
Site Public Contact
787-395-7085
Bayamón, Puerto Rico 00961
Site Public Contact
787-780-2865
Manatí, Puerto Rico 00674
Site Public Contact
787-621-4397
San Juan, Puerto Rico 00917
Site Public Contact
787-274-3387
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
Site Public Contact
787-763-1296
More Details
- NCT ID
- NCT05896189
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed 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.