Mobile Health Intervention for Breast Cancer

No longer recruiting at 3 trial locations

Overseen By Ilana Graetz, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Capecitabine

Disqualifiers: ECOG status > 2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health device designed to help women with triple-negative breast cancer remember to take their oral chemotherapy on time. The device, called the SMRxT smart pill bottle, sends reminders and tracks symptoms. The trial aims to determine if this device improves adherence to treatment plans. Women with non-metastatic breast cancer who are taking capecitabine (Xeloda) may be suitable candidates. Participants must have a mobile phone to receive text messages. As an unphased trial, this study offers participants the chance to contribute to innovative solutions that could enhance treatment adherence for future patients.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you must have a prescription for capecitabine/Xeloda to participate.

What prior data suggests that this mobile health device is safe for improving oral chemotherapy adherence?

Research shows that the SMRxT smart pill bottle is easy to use and helps people take their medicine as prescribed, which is important for effectively managing health conditions. These devices also improve patient satisfaction by reminding them to take their medicine on time. No major reports of negative effects from using the smart pill bottle itself have emerged, indicating it is safe to use. Although the smart pill bottle is not a medicine, it can help patients adhere better to their treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses a SMRxT smart pill bottle to improve medication adherence for breast cancer treatment. Unlike traditional treatments that rely solely on patients remembering to take their medication, this smart device provides reminders for missed or incorrect doses during the standard capecitabine/Xeloda treatment cycle. By ensuring patients stick to their medication schedule more effectively, the intervention aims to enhance treatment outcomes and potentially improve the quality of life for those undergoing chemotherapy. This innovative approach addresses a common challenge in cancer care—medication adherence—by leveraging technology to support patients in their treatment journey.

What evidence suggests that the SMRxT smart pill bottle is effective for improving oral chemotherapy adherence in non-metastatic triple negative breast cancer?

Studies have shown that smart pill bottles can help people follow their medication schedules more effectively. In this trial, participants in Group I will receive the SMRxT smart pill bottle, which not only improves how regularly breast cancer survivors take their medication but also boosts their confidence in managing their treatment. The SMRxT smart pill bottle sends reminders and tracks when medicine is taken, helping ensure patients adhere to their medication plan. Research suggests that these smart bottles help patients remember to take their medication more often, which is crucial for the success of oral chemotherapy. This tool may enhance patients' ability to manage their treatment and improve health outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Ilana Graetz, PhD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 18 with non-metastatic triple negative breast cancer who are prescribed capecitabine/Xeloda. Participants must be able to follow study procedures, have text messaging on their mobile phone, and understand the study's risks and benefits.

Inclusion Criteria

I am prescribed capecitabine/Xeloda.

Evidence of an online informed consent indicating awareness of the risk and benefits of study participation

I have been diagnosed with breast cancer.

Exclusion Criteria

My daily activity is significantly limited due to my health.

Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a SMRxT smart pill bottle and report symptoms weekly during 3-week capecitabine/Xeloda treatment cycles

12 weeks

Weekly symptom reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Health Device

Trial Overview The trial tests if a smart pill bottle (SMRxT) can help patients take oral chemotherapy on time and monitor symptoms. It assesses how practical and acceptable this mobile health device is for improving medication adherence.

How Is the Trial Designed?

Group I: Group I (SMRxT smart pill bottle) Experimental Treatment 4 Interventions

Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.

Group II: Group II (standard of care) Active Control 3 Interventions

Patients receive a SMRxT smart pill bottle and standard of care.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9584037/

Effect of a Smart Pill Bottle Reminder Intervention on ... Reminder intervention using smart pill bottles was effective in improving medication adherence and medication self-efficacy among breast cancer survivors.

2. journals.lww.com journals.lww.com/cancernursingonline/fulltext/2022/11000/effect_of_a_smart_pill_bottle_reminder.17.aspx

Effect of a Smart Pill Bottle Reminder Intervention on... Reminder intervention using smart pill bottles was effective in improving medication adherence and medication self-efficacy among breast cancer survivors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10546835/

Evaluating the Effectiveness of Mobile Health in Breast ... This review analyzes methodologies used in recent studies to determine the effects of mHealth applications and wearable devices on outcomes for patients with ...

4. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1301&context=medoncfp

A Smart Pill Bottle and Text Messaging Intervention for ... TXT-based interven- tions have shown success in various medical contexts, including breast cancer therapy adherence [14, 15], while. Chatbots ...

5. cancernursingtoday.com cancernursingtoday.com/post/smart-pill-bottle-and-app-may-improve-adherence-to-oral-antiestrogen-therapy-among-breast-cancer-survivors

Smart Pill Bottle and App May Improve Adherence to Oral ... A reminder intervention using a smart pill bottle paired and an app can improve medication adherence among breast cancer survivors receiving ...

6. jmcp.org jmcp.org/doi/10.18553/jmcp.2019.25.11.1244

Effect of a Smart Pill Bottle and Pharmacist Intervention on ... CONCLUSIONS: In this study, SPB interventions were associated with increased medication adherence and patient satisfaction. This pilot also ...

7. researchgate.net researchgate.net/publication/355459542_Effect_of_a_Smart_Pill_Bottle_Reminder_Intervention_on_Medication_Adherence_Self-efficacy_and_Depression_in_Breast_Cancer_Survivors

(PDF) Effect of a Smart Pill Bottle Reminder Intervention on ... Objective: The aim of this study was to evaluate the effect of a reminder intervention-a smart pill bottle paired with the Pillsy mobile ...