NRG-CC015 (HEAL-ABC): A study to examine mindfulness training to improve mental health and well-being in younger breast cancer survivors.

The purpose of this study is to compare different approaches to delivering mindfulness training in younger breast cancer survivors with depressive symptoms. The study will help the study team find out which approach to delivering mindfulness training will work better to improve mental health and well-being in younger breast cancer survivors. There will be about 402 people taking part in this study.

If you decide to take part in this study, you will join one of three mindfulness training programs for 6 weeks and complete assessments before and up to six months after training. The mindfulness programs will be delivered in one of three ways: 1) online via Zoom in a group with other study participants; 2) using a specially-designed app that includes the same training material and activities as the Zoom group; or 3) using special mindfulness meditations. If you are English language speaking, you will be randomized to one of these three programs, and if you are Spanish language speaking, you will be randomized to the first or third program. Trained research staff from the University of California, Los Angeles (UCLA) will help you learn how to use each of the different digital programs depending on which one you are assigned to, and they will provide tablets and internet access for those who need it to access the programs. You will also be asked to complete questionnaires electronically online before and after receiving the mindfulness training. Your total participation in this study will be about 9 months.

The usual approach for participants who are not in a study is to get advice about the management of their depressive symptoms from their clinicians.

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

There may be some risks that the study clinicians do not yet know about.

There may or may not be a direct benefit to you. However, it may help the study clinicians understand more about treating depressive symptoms in younger 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 study will provide a computer tablet with data capability and internet access 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 (electronic questionnaires), 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 additional 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:

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