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Behavioral Intervention

Mobile Health for Breast Cancer

N/A

Recruiting

Led By Gelareh Sadigh

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish

PATIENT STEP 0: Patient must be >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two different methods of helping patients with metastatic breast cancer take their medication correctly. One method involves using a device called WiseBag and receiving text message reminders, while the other method only

Who is the study for?

This trial is for metastatic breast cancer patients taking CDK4/6 inhibitors, fluent in English or Spanish, and healthcare providers involved with such patients. Patients must have started treatment within 30 days before joining or plan to start soon after. Providers need experience with a patient on CONCURxP who had less than 85% adherence.

What is being tested?

The study tests the effectiveness of the CONCURxP platform, which includes a medication monitoring device (WiseBag) and text reminders, against enhanced usual care using only WiseBag to improve medication adherence in metastatic breast cancer patients.

What are the potential side effects?

Since this trial focuses on monitoring adherence rather than testing new drugs, side effects are not primarily related to medications but may include potential privacy concerns or stress from constant monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fluent in English or Spanish, both written and spoken.

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I am 18 years old or older.

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My breast cancer is hormone receptor positive and HER2 negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence using electronic monitoring

Secondary study objectives

Adherence using self-report

CDK4/6i persistence

Financial worry

+4 more

Other study objectives

CONCURxP arm patients and their provider experience

Characteristics of National Cancer Institute Community Oncology Research Program (NCORP) site patient population and the enrollees in EAQ221CD.

Healthcare utilization

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ARM C (Non-patient interview)Experimental Treatment1 Intervention

Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

Group II: ARM B (CONCURxP program)Experimental Treatment6 Interventions

Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion.

Group III: ARM A (Enhanced usual care)Experimental Treatment4 Interventions

Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Telemonitoring

2013

N/A

~120

Patient Navigation

2017