Mobile Health for Adherence in Breast Cancer Patients

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT06112613
Trial Phases:		Protocol IDs:	EAQ221CD (primary) EAQ221CD ECOG-ACRIN-EAQ221CD NCI-2023-02646
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT06112613

Summary

This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

Objectives

PRIMARY OBJECTIVE:
I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.

SECONDARY OBJECTIVES:
I. To compare CDK4/6i adherence at 12 months after randomization captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms.
II. To compare CDK4/6i persistence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.
III. To compare symptom burden at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.
IV. To compare quality of life at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.
V. To compare patient-provider communication at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.
VI. To compare self-efficacy for managing symptoms at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.
VII. To compare financial worry at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.

EXPLORATORY OBJECTIVES:
I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from randomization to 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.
II. To compare healthcare utilization at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms.
III. To compare progression-free survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.
IV. To compare overall survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.
V. To describe CONCURxP (Arm B) patients and their provider experience with various implementation outcomes.
VI. To compare characteristics of the National Cancer Institute Community Oncology Research Program (NCORP) site patient population with the enrollees in EAQ221CD.

OUTLINE: Patients are randomized into 1 of 2 arms. Non-patient participants are assigned to arm C.

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

ARM B: 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.

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

After completion of study intervention, patients may be followed up to 6 months.

Treatment Sites in Georgia

Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

Phoebe Cancer Center at Phoebe Putney Memorial Hospital
425 Third Avenue
Albany, GA 31702
229-312-5091
www.phoebehealth.com

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.