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Behavioral Intervention

ARM B (CONCURxP program) 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence using electronic monitoring

Secondary outcome measures

Adherence using self-report

CDK4/6i persistence

Financial worry

+4 more

Other outcome measures

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

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

Patient Navigation

2017

Completed Phase 2

~38910

Health Telemonitoring

2013

N/A

~120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,031 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,512 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

Gelareh SadighPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

760 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants currently underway for this clinical trial?

"Absolutely. Information available on clinicaltrials.gov confirms that this study is actively seeking participants. The trial was first posted on October 31, 2023, and the most recent update occurred on December 14, 2023. A total of 410 patients are being recruited from a diverse range of locations spanning across 87 sites."

Answered by AI

What is the current number of individuals enrolled in this clinical trial?

"To adequately conduct this clinical trial, a total of 410 eligible participants must be enrolled. Patients have the opportunity to participate in various locations including Carle at The Riverfront in Danville, Illinois and ThedaCare Cancer Care - Waupaca in Waupaca, Wisconsin."

Answered by AI

Are multiple medical centers in the city conducting this clinical investigation?

"There are a total of 87 available locations for this clinical trial. Some notable sites include Carle at The Riverfront in Danville, ThedaCare Cancer Care - Waupaca in Waupaca, and UC Irvine Health/Chao Family Comprehensive Cancer Center in Orange. Additionally, there are 84 other locations participating in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mobile Health for Adherence in Breast Cancer Patients

2024. "Mobile Health for Adherence in Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112613.

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