Mobile Health for Adherence in Breast Cancer Patients

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Carcinoma
• HER2-Negative Breast Carcinoma
• Hormone Receptor-Positive Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Electronic Health Record Review — OTHER
  Ancillary studies
• Health Promotion and Education — OTHER
  Receive access to educational materials
• Health Telemonitoring — PROCEDURE
  Utilize the WiseBag medication dispenser
• Interview — OTHER
  Complete an interview
• Patient Navigation — BEHAVIORAL
  Receive healthcare provider follow ups as part of the CONCURxP program
• Survey Administration — OTHER
  Ancillary studies
• Text Message-Based Navigation Intervention — OTHER
  Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program

Study Details

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.

Key Dates

Start date

Jan 26, 2024

Status verified

May 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

410 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: ARM A (Enhanced usual care)
  Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.
• Experimental: ARM B (CONCURxP program)
  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.
• Experimental: ARM C (Non-patient interview)
  Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

Primary Outcome Measure

Adherence using electronic monitoring [ Time Frame: At 12 months after initiation of medication ]

Locations (499)

Find similar trials in Fairbanks, AK

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