Smartphone App Monitoring for Breast Cancer Treatment

(SMART-ER Trial)

No longer recruiting at 2 trial locations

Overseen By Grace Mberekpe

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Adjuvant endocrine therapy

Must not be taking: Abemaciclib, Olaparib

Disqualifiers: Previous tamoxifen/aromatase inhibitor, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app for symptom tracking helps women adhere to their breast cancer treatment. Participants will use the app to report their symptoms at various times after starting hormone therapy. The goal is to catch symptoms early, manage them better, and improve treatment continuation. Women with hormone receptor-positive breast cancer who are about to begin hormone therapy and have factors that might lead to early discontinuation, such as existing health issues or medication for depression, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment adherence and quality of life for future patients.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot receive chemotherapy, adjuvant abemaciclib, adjuvant olaparib, or any investigational agents during the study. You can continue medications for depression and/or anxiety, as well as treatments for other listed comorbid conditions.

What prior data suggests that this smartphone app monitoring is safe for breast cancer treatment?

Research has shown that the Outcomes4Me app helps breast cancer patients track symptoms and manage their care. Patients can record symptoms, assisting both them and their doctors in making informed treatment decisions.

As a digital tool, the app does not involve medication or physical treatment, eliminating typical safety concerns like side effects found in drug trials. Users have reported that the app is easy to use and helps them stay organized with their treatment plans.

In summary, the Outcomes4Me app is considered safe. It offers a way to track symptoms and manage health without adding physical risk to the user. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the smartphone app monitoring for breast cancer treatment because it offers a new way to support patients undergoing adjuvant endocrine therapy. Unlike traditional methods that rely heavily on in-person consultations and self-reporting, this app allows patients to complete patient-reported outcome surveys from the convenience of their phones. This approach can provide real-time data to healthcare providers, potentially improving adherence to therapy and catching issues earlier. Additionally, the app's feedback loop includes input from study and clinical teams, which can enhance the overall effectiveness of the treatment process. This innovation holds promise for making cancer care more personalized and responsive.

What evidence suggests that the PRO Surveys via Outcomes4Me app are effective for improving adherence to endocrine therapy?

Research has shown that the Outcomes4Me app, which includes surveys for patients to report their symptoms, benefits breast cancer patients. In this trial, participants will use the app to complete patient-reported outcome (PRO) surveys at various intervals after starting adjuvant endocrine therapy. The app provides information and helps track symptoms, which is crucial for managing side effects. Managing symptoms is key to continuing treatments like adjuvant endocrine therapy. Although one study found that early symptom monitoring did not improve quality of life, the app remains useful for personalized cancer care. Tracking symptoms can greatly improve outcomes, as demonstrated in other types of cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Jenni Sheng, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for women aged 18+ with stage I-III hormone receptor-positive invasive breast cancer. Participants must be able to use a smartphone with internet access and download the Outcomes4Me app, as they'll complete surveys on it. They should be starting adjuvant endocrine therapy soon and can't be in other symptom management or adherence trials.

Inclusion Criteria

Study Team/Clinical Team Member Inclusion Criteria: Provision of written informed consent, Stated willingness to comply with study procedures, A member of the study team or clinical team at a Johns Hopkins or Virginia Commonwealth University clinical site where at least 2 patient participants have enrolled, at least one of whom has passed the T2 survey time point and at least one of whom has had an alert for a severe or worsening symptom, Able to participate in an interview in English

Along with the previous requirements, you should be either younger than 40 or older than 70, identify as Black or African, take medication for depression or anxiety, have certain health conditions, or report moderate to severe symptoms.

My breast cancer is hormone receptor-positive and not beyond stage III.

Exclusion Criteria

I am not currently taking olaparib while participating in this study.

Patients may not participate in another trial evaluating an intervention to support endocrine therapy adherence and/or persistence during participation in this study

I am not starting hormone therapy for conditions like LCIS, DCIS, or atypical hyperplasia without invasive breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline PRO surveys and assessments including demographics and financial hardship

1 week

1 visit (virtual)

Treatment Monitoring

Participants complete PRO surveys at 2, 4, 8, and 12 weeks after endocrine therapy initiation to monitor symptoms and adherence

12 weeks

4 visits (virtual)

Follow-up

Participants complete an End-of-Study Evaluation and feedback about the study intervention

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PRO Surveys via Outcomes4Me app
• Semi-structured Interview

Trial Overview

The study tests if using the Outcomes4Me app to collect patient-reported outcome surveys is practical by looking at how many patients finish them. It aims to see if tracking symptoms this way helps manage them better, which could improve sticking with treatment over time.

How Is the Trial Designed?

Group I: Team Member Participants Experimental Treatment 1 Intervention

Feedback about the intervention will be obtained from patients and from members of the study teams and clinical teams caring for the patients who participate.

Group II: Patient participants Experimental Treatment 1 Intervention

Patients with risk factors for adjuvant endocrine therapy non-adherence or early discontinuation will complete patient-reported outcome (PRO) surveys via smart phone app at baseline and 2, 4, 8 and 12 weeks after adjuvant endocrine therapy initiation.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Outcomes4Me

Industry Sponsor

Trials

2

Recruited

170+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

Published Research Related to This Trial

A feasibility study involving 16 breast cancer patients indicated that an app-based patient-reported outcome (PRO) monitoring system is generally acceptable, with participants expressing satisfaction with the weekly questionnaires.

Technical issues with the app, such as push notifications not working on some smartphones, need to be addressed for the PRO B study to proceed effectively, but participants felt they could manage weekly reporting for a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study. Hage, AM., Gebert, P., Kühn, F., et al.[2022]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

The study involved 63 eligible men with metastatic prostate cancer, with 54 (86%) enrolling and achieving a high compliance rate of 97% in completing the PRO-CTCAE questionnaire, indicating strong feasibility for electronic symptom surveillance.

Both patients and oncologists found the electronic PRO-CTCAE self-reports improved communication about treatment side effects, suggesting that this method could enhance the management of symptomatic toxicities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients. Baeksted, C., Pappot, H., Nissen, A., et al.[2022]

A web-based interface (WBI) for patient symptom self-reporting during chemoradiation therapy was found to be feasible and well-received, with 92% of patients reporting easy access to the surveys.

Despite high satisfaction, survey fatigue was noted, as 58% of patients felt the surveys were too long or frequent, suggesting a need for a more patient-centered approach to improve engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. Ma, TM., Yang, T., Philipson, R., et al.[2023]

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

A study involving 25 women with breast cancer revealed that using a real-time tracking tool improved the consistency of symptom tracking compared to traditional methods, which were often fragmented.

Participants reported that the tracking tool helped them identify patterns in their symptoms, provided psychosocial comfort, and enhanced their communication with healthcare providers, suggesting it could lead to better symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probing the benefits of real-time tracking during cancer care. Patel, RA., Klasnja, P., Hartzler, A., et al.[2022]

The PRO-SMART application was successfully used by 100 out of 101 cancer patients undergoing chemotherapy, demonstrating a high accessibility rate of 90.1% for electronic patient-reported outcomes.

Using PRO-SMART led to a significant increase in the reporting of symptomatic adverse events related to chemotherapy, indicating that it effectively enhances symptom monitoring and patient engagement in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and accessibility of electronic patient-reported outcome measures using a smartphone during routine chemotherapy: a pilot study. Bae, WK., Kwon, J., Lee, HW., et al.[2019]

A pilot study involving 40 women with breast cancer showed that using a symptom management mobile application alongside usual care led to better quality of life and lower severity of depression compared to those receiving only usual care.

The intervention group experienced less decline in general health and physical functioning during chemotherapy, suggesting that the mobile app may effectively support emotional and physical well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. Seven, M., Paşalak, Ş., Bagcivan, G., et al.[2022]

The implementation of electronic patient-reported outcomes (ePROs) in a large community oncology network showed high initial utilization, with 73% of enrolled patients completing at least one assessment, indicating that ePROs can effectively monitor symptoms during chemotherapy.

However, compliance with ePRO assessments declined over time, from 72% to 52% over 10 weeks, highlighting the need to address barriers such as reminder prompts and clinician engagement to maintain high levels of participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multisite Community Oncology Practice: Dancing the Texas Two-Step Through a Pandemic. Patt, D., Wilfong, L., Hudson, KE., et al.[2022]

The study demonstrated that collecting daily self-reported sleep disturbance data from breast cancer patients undergoing chemotherapy via a smartphone app is feasible, with a compliance rate of 45% over 90 days.

Compliance was higher among unemployed women and those who began reporting immediately after enrollment, suggesting that targeting specific subgroups may enhance participation in future mobile health studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily collection of self-reporting sleep disturbance data via a smartphone app in breast cancer patients receiving chemotherapy: a feasibility study. Min, YH., Lee, JW., Shin, YW., et al.[2022]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

The study involving 57 breast cancer patients showed that using a mobile application for symptom monitoring significantly improved control over physical symptoms compared to a control group, as indicated by lower scores on the Memorial Symptom Assessment Scale (MSAS).

Patients using the mobile app also reported better quality of life outcomes, including higher scores in areas such as overall quality of life and sexual function, suggesting that mobile symptom monitoring can enhance patient well-being during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of the Mobile Application-Based Symptom Monitoring Process on the Symptom Control and Quality of Life in Breast Cancer Patients. Öztürk, ES., Kutlutürkan, S.[2021]

A randomized controlled trial involving 300 women with early-stage, hormone receptor-positive breast cancer is testing a web-enabled app designed to improve adherence to adjuvant endocrine therapy (AET) by managing symptoms and providing feedback.

The study aims to assess the app's impact on medication adherence, symptom burden, and quality of life over six months, with a focus on addressing racial disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. Paladino, AJ., Anderson, JN., Krukowski, RA., et al.[2022]

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