NRG-CC011: A Study to Examine Computerized Training to Improve Concentration, Learning New Things, and Remembering in Breast Cancer Survivors.

This study is for breast cancer survivors with cancer-related cognitive impairment (CRCI). Cancer-related cognitive impairment is when a person has trouble concentrating, learning new things, remembering, or making decisions that affect their everyday life.

The study team will be comparing different approaches of computerized cognitive training methods in breast cancer survivors with cancer related cognitive impairment.

The study will help to determine which approach of computerized cognitive training methods will work better to improve the ability to concentrate, learn new things, remember, and make decisions that affect daily life.

If you decide to take part in this study, you will join one of two computerized cognitive training groups. Whichever group you are assigned to you will be asked to complete activities that will require you to attend to, learn, process and remember information.

There is a risk that you may feel uncomfortable answering some of the questions asked or completing the cognitive assessment in this study. You also may feel uncomfortable being asked sensitive or private questions about things you normally do not discuss.

If you agree to take part in this study, there may or may not be a direct benefit to you.It is hopeful that information from this study will help researchers learn more about treating cognitive impairment in breast cancer survivors in the future.

There will be no costs to you or your insurance company for taking part in this study.The study staff will call you so that you do not incur long distance phone charges (if this applies to you). The research staff will provide a stamped envelope if you choose to return questionnaires by mail to avoid postage costs.The study will provide a computer tablet with data capability and hot spots to ensure access as needed.If you chose to use a personal smart phone or tablet with a personal cellular plan to answer the online questions, there may be extra costs to your data plan.

After completing each of the assessments (both surveys and cognitive assessments), you will receive compensation of a $25 electronic gift card for each assessment (up to $100 for all 4 assessments) for your participation.The research may lead to new tests or other products for sale. If it does, you will not get any payment.

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer