CONCURxP: Mobile Health for Adherence in Breast Cancer Patients

Mobile Health for Adherence in Breast Cancer Patients

Why consider participating in this study?

Research studies are an important way to test the effectiveness of new approaches for supporting patients being treated for breast cancer.
The usual approach (the care most people get) to treat your type of breast cancer is to take oral targeted therapy pills. Patients usually manage taking this medication on their own without additional communication with their doctor between visits.
The oral targeted therapy for this study, also known as a CDK4/6 inhibitor, includes any of the following medications: Palbociclib (Ibrance), Ribociclib (Kisqali), Abemaciclib (Verzenio).
The EAQ221CD/CONCURxP study will monitor medication use with text message reminders and alerts. The study aims to find out if these reminders and other tools can make it easier for patients to stick to the medication schedule that the doctor ordered

What does this study involve?

If you decide to take part in this study, you will get a special pouch, called the WiseBag™, to store your CDK4/6 inhibitor medication. The WiseBag keeps track of when you open it, so it knows exactly when you’ve taken your medication. This allows you to keep track of your doses in real time.
You will be assigned by chance (randomized) to one of two groups. You will have an equal chance of being in Group 1 or Group 2.

Group 1

Every month, you will get text and email messages with helpful information about your medication. You will also be asked questions about any changes to your prescription.

Group 2

You will get text and email messages as you go along, in real time, if the WiseBag senses that you may have missed a dose or accidentally taken a double dose. If this happens frequently, your care team will be told so that they can help support you. You will also have access to a website where you can check details about your medication use.
With your permission, some details will be shared with community partners if you need financial or other support. For example, if it’s hard to afford your medication, you may be asked if you would like to connect with an organization that could help with costs.

Both groups of study participants will be asked to complete a survey about themselves, their health, their doctor, and other study-related items. You will be asked to fill out this survey four times: when you first join the study, and then at 3, 6, and 12 months after joining.

The total time you will be in the study is about 12 months.
Each survey will take about 30 minutes to complete. They can be completed online or on paper and you don’t have to answer any question that makes you feel uncomfortable.
You will receive a gift card after completing each survey

Who will take part in this study?

Approximately 390 people with breast cancer will take part in EAQ221CD/CONCURxP. In order to participate in the study, you must:

Be English or Spanish speaking
Have a mobile phone and agree to send/receive text messages
Have an email address
Start your CDK4/6 inhibitor either within 60 days prior to, or 30 days after of joining EAQ221CD/CONCURxP

You can decide to stop taking part in the study at any time, even after you have enrolled. Please note that the WiseBag will need to be returned within 30 days of when you complete or leave the study. You will be mailed a pre-paid package to be used to return your WiseBag.

What are the costs in participating in this study?

There is no medical care or testing being given as part of this study, and there are no expected costs to you for taking part in the study (including the WiseBag, which is provided free of charge). Taking part in EAQ221CD/CONCURxP should not require you to do anything differently than you would for your usual breast cancer treatment.
Standard text messaging rates may apply based on your phone plan and carrier.
Participants will receive a gift card valued at $10 at completion of the first survey, $20 for the second survey, $30 for the third survey, and $40 for the fourth survey.

How to use the Wisebag

English Version

Versión en Español

Patient Facing Video

Study Materials

Physician Fact Sheet

Patient Study Summary

Useful Study Links

To request a one-on-one session with us with your site please use this link: Calendly
To request a demo Wisebag or patient brochures for your site use this link: Request Materials
If your site has not completed their site activation survey use this link: Site Activation Survey

Who is sponsoring this trial?

Clinical trial EAQ221CD is being led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), which focuses its research on adults who have or are at risk of developing cancer. ECOG-ACRIN receives funding for this trial from the National Cancer Institute, part of the National Institutes of Health. This study is funded by National Cancer Institue (R01CA262312).

If you would like to know more:

About the EAQ221CD/CONCURxP study, talk with your doctor, or:

Visit www.ecog-acrin.org and search EAQ221CD, then select the link to the EAQ221CD Home Page.
If you are seeking information about the locations where the study is available, scroll down the page to Locations and Contacts and click the + sign.
Call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237)

General cancer information: visit the NCI website at www.cancer.gov

About ECOG-ACRIN: