Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

People who will be starting or have started an oral anti-cancer treatment other than hormonal therapy in the past 4 weeks.

Study doctors want to know if people on oral anti-cancer treatment have less severe symptoms and fewer visits to the emergency room or urgent care with telephone symptom monitoring and other support. Additionally, researchers want to know if the doctors and nurses in your doctor’s offices view symptom monitoring and other support as useful.

There are two study groups. Your doctor’s office will be assigned randomly (by chance) to be in one of the two study groups.

If your doctor’s office is in group 1, you will receive your usual care and weekly automated symptom monitoring telephone calls over the 17 weeks. The calls will be at a good time for you and will last about 15 minutes. You can change your preferred time at any point by calling the study office.

If your doctor’s office is in group 2, you will receive your usual care and weekly automated symptom monitoring telephone calls over the 17 weeks. The calls will be at a good time for you. Each call will last about 20 minutes. You can change your preferred time at any point by calling the study office. People in group 2 will also get a printed symptom management handbook with ideas to help you manage your symptoms at home. This handbook is available in English or Spanish. You may also get calls from a study counselor for symptoms related to your mood during the first 12 weeks. If you are offered counseling, counseling calls will be about 30 minutes at a good time for you and will be free of charge.

The usual approach is to discuss symptoms during doctor’s office visits. People may also contact their doctor or nurse by phone or internet to get advice on how to relieve symptoms. This advice might include ways to monitor and manage symptoms while taking oral anti-cancer treatment.

If you choose to take part in this study there is a risk you may feel uncomfortable answering some of the questions. You do not have to do any study-related task that feels uncomfortable or upsetting. You have the option of stopping participation at any time during the study or skipping some of the questions or calls. As with any research study, a loss of confidentiality is a possible risk. We have steps in place to minimize this risk and believe this risk is small.

If you agree to take part in this study, there may or may not be a direct benefit to you. The hope is that in the future, information from this study will help address symptoms during oral anti-cancer treatment.

You will be in the study for 17 weeks.

Yes, because taking part in this study is voluntary. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, you will receive the usual care from your doctor’s office. As part of usual care, you can discuss symptoms during doctor’s office visits and you can contact your doctor or nurse by phone or patient portal to get advice on how to relieve symptoms.

You will receive the usual care and cancer treatment while you take part in the study. You and/or your insurance plan will need to pay for the costs of your cancer treatment and the medical care including any doctor visits for your cancer while you take part of the study. This includes:

• Your insurance co-pays and deductibles. 
• The costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety and prevent and treat side effects. 

You and/or your insurance provider will not have to pay for the study surveys or reports of your symptoms to your doctor’s office. Your insurance provider is expected to pay for exams and tests in the same way as if you were not participating in this study. 

You may incur costs for phone use to complete the interviews or automated calls. 

You will not be paid for taking part in this study. The research may lead to new tests, drugs, or other products for sale. If it does, you will not get any payment.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology 
• The National Cancer Institute (NCI) Central Investigational Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• Michigan State University 
• University of Miami 
• University of Arizona

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:

physician offices

hospitals

clinics

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