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J1878 - The Johns Hopkins Breast Cancer Program Initiative to Reduce the Discontinuation Rate of (Neo)adjuvant Endocrine Therapy through Symptom Monitoring and Management: A Feasibility Study
Protocol Number:
Karen Smith
Sibley Memorial Hospital
Johns Hopkins Kimmel Cancer Center in Baltimore
This study is being done to collect and monitor the side effects that breast cancer patients report while taking endocrine therapy through questionnaires completed on a mobile-phone based app. In addition, this research is being done to see if evaluating these patient-reported side effects within a given timeframe will have any impact on how side effects are controlled and on patient willingness to continue endocrine therapy.
This study is open to women with Stage 0-III, hormone-receptor positive breast cancer who are starting endocrine therapy. To participate, you must have a start phone and be able to read and understand English.
The study will involve downloading an app on your phone, called Thrive, and answering questionnaires on your phone through the app. If you are interested in participating, you will meet with a member of your care team who will explain the study to you. A member of the team will help you download the app, if it is not already downloaded on your phone. The app will be downloaded to your phone from the App Store (Apple devices) or Google Play (Android devices). The team will assist you in enrolling in the questionnaire portion of the app. The questionnaires will take about 5-7 minutes and ask about things like your emotions, pain, aches, sexual health, memory, concentration, and fatigue. The app will prompt you to complete the same questionnaires again in about one month, three months, six months, and at one year for a total of 5 surveys. You will be in this study for one year.Your answers are private but they are recorded in the app and shared with your care team to help manage your care in real-time. As a part of this research study, your care team and the research team will also have access to the personal health information in your medical record. In some cases, your answers may trigger a notice to your care team. If your answers trigger a notice to your care team, they, may contact you in between standard visits to help better manage your symptoms during endocrine therapy. In these cases, your answers from the app may also be recorded in your medical record. We will analyze the answers from all patients together to improve care.
Last Update
08/08/2020 05:02 AM