This study will enroll up to 415 adult participants who have been diagnosed with stage I-III cancer and who are currently receiving systemic treatment (radiation, chemotherapy, and/or immunotherapy); have received systemic treatment within the last 6 months; or who have an established treatment plan that includes some form of systemic treatment.

Participation in this study lasts about 12 weeks, and will require approximately 12-20 hours of your time (on average 1 to 2 hours per week).

Randomization: If you choose to participate in this study, you will be randomly assigned to receive one of the digital therapy apps. You will have a 50/50 chance of being assigned one or the other apps. Both groups are equally important for the study.

Use of the digital therapy apps: You will be asked to use your smartphone or tablet to download your assigned app. Over a period of approximately 12 weeks, you will be asked to complete ten sessions, each around 60 minutes in length. Each session will contain information on a single topic with guided exercises at the end. Some sessions will also have additional exercises for you to complete before the next session. The application may also have additional interactive opportunities. It is ideal to complete one session per week, but you will have up to 12 weeks to complete all ten sessions if you need extra time.

Complete Questionnaires: Regardless of which group you are randomly assigned to, you will be asked to complete four questionnaires via Curebase. Curebase is a digital platform used to run studies. You will complete your first questionnaire before you start the study, which will ask questions about who you are (age, marital status, race/ethnicity, education) as well as questions about your mental health, symptoms, and wellbeing. You will also be asked to complete three additional follow-up questionnaires every 4 weeks (weeks 4, 8, and 12 of the study). These questionnaires include surveys about your health and symptoms, quality of life, positive and negative mood states, knowledge and confidence to manage your health, and social and emotional skills. We won’t ask you to fill out all of the surveys every 4 weeks, but some of them will repeat at every time point. The final follow-up questionnaire will also ask you about your experience with using the app.

You will complete the entire study from home on your smartphone or tablet. You can also opt to use a laptop or computer to complete questionnaires. There will be no costs or charges to you for taking part in this study.

Total possible compensation for participation in this study is up to $200. You will receive $25 after completion of each of the four sets of questionnaires. Additionally, all participants who complete the entire study will receive $100 at the end of the study. If you voluntarily leave the study for any reason before finishing all study procedures you will only be compensated for those assessments/visits you have completed. Your payment will be processed by Curebase. You will be requested to use an existing PayPal account, or to create a new one, in order to receive payment. PayPal will have access to your personal information, including your connected bank account information. Alternative payment options are available.  

You may or may not receive some benefits, such as improved physical and mental wellbeing, from the digital apps. We cannot and do not guarantee or promise that you will benefit from using the app.

We will ask you to provide some personal and health information, such as:

Your name, email address, telephone number, zip code
Your date of birth, gender, ethnic and racial background
Lifestyle information; health and medical history
Data resulting from your questionnaires
Data from your use of the app (e.g., date and timestamp of your progress through the app sessions)

You will also be asked to fill out an electronic medical records authorization form to give us permission to view your medical records. This will give us a better understanding of your cancer diagnosis and treatment and your general health status.

Appropriate measures will be taken to protect your personal information. These measures will comply with data protection and privacy laws that apply. You can connect to the Sponsor’s privacy policy link at https://bluenotetherapeutics.com/privacy/.

Your contact details will not be disclosed to anyone except a small number of people with direct responsibility for managing the study and will be treated as strictly confidential. The contact details you provide will be used only to communicate with you about the study and your participation, such as reminders to complete questionnaires.

Blue Note Therapeutics staff, regulatory agencies, review boards, and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. It may also be necessary to pass information that identifies you such as your name and date of birth to Blue Note Therapeutics if there is a serious safety risk. This information will only be shared between select members of the study Sponsor and delegate organizations who are responsible for safety monitoring of the study.

Your data will be de-identified for research, meaning personal identifiers (names, addresses, and other identifying information) are removed from the health information you provide (e.g., questionnaire responses and information from medical records). The information that pertains to you will be coded by a special study ID code, not your name. The link between ID codes and names will be kept separate from the de-identified dataset used for research. Your name will be used only when addressing you personally—for example, in a phone conversation with you. Within the application, there may also be places where you can choose to share your name or other identifying information.

Blue Note Therapeutics and other scientists and organizations use de-identified information to learn about diseases and medicines. It may be used for this study or other purposes, including future research. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medical devices. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data.

Your personal information will be used for only as long as needed for the study and future research, with your consent. It may be retained for longer, where required by law. Blue Note Therapeutics must retain data from clinical trials for up to 5 years. If you withdraw from the research, no new information will be collected, but information already in the database will remain with the study data.

This study is funded and sponsored by Blue Note Therapeutics, Inc. They are a prescription digital therapeutics company that focuses on easing the emotional burden of cancer for patients. They are working with a company that specializes in clinical trials to help run this study.