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New treatment option for Breast Cancer
Official title Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT05896189
What this study is testing
- What it's testing
- This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal...
- 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...
- The participant must be able to understand, speak, read, and write in English or Spanish.
You likely can't join if
- 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...
- Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of...
- Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery.
See the full eligibility 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)...
- The participant must be able to understand, speak, read, and write in English or Spanish.
- 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...
- Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Gilbert, Arizona, United States
- Goodyear, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Surprise, Arizona, United States
- Tempe, Arizona, United States
- Fort Smith, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Bakersfield, California, United States
- Burbank, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Chico, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
+ 469 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Gilbert, Arizona, United States; Goodyear, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States and 483 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.