Smartphone App Monitoring for Breast Cancer Treatment

(SMART-ER Trial)

Recruiting at 1 trial location

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The key hypothesis for this study is that collection of the PRO surveys via the Outcomes4Me app is feasible, as measured by survey completion rates. In addition to informing feasibility, this study will provide information about symptom trajectories, symptom management interventions, and early endocrine therapy adherence and persistence. 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. Since symptoms and side effects are a key driver of adjuvant endocrine therapy non-adherence and non-persistence, the investigators anticipate that enhanced detection of symptoms via use of PRO surveys will result in improved symptom management and, could thereby support treatment adherence and persistence. This pilot study will assess the feasibility of the PRO survey intervention. In this pilot study, 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.

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 data supports the idea that Smartphone App Monitoring for Breast Cancer Treatment is an effective treatment?

The available research shows that using smartphone apps for monitoring symptoms in breast cancer treatment can be effective. One study found that real-time tracking tools helped patients consistently track their symptoms, see patterns, and communicate better with their doctors. Another study indicated that electronic symptom monitoring is linked to better health outcomes and satisfaction among patients receiving chemotherapy. Additionally, a web-enabled app was shown to help manage symptoms and improve medication adherence, which is crucial for reducing the risk of cancer recurrence and mortality. ^{1 2 3 4 5}

What safety data exists for the smartphone app monitoring breast cancer treatment?

The safety data for smartphone app monitoring in breast cancer treatment is primarily focused on the feasibility and effectiveness of patient-reported outcomes (PRO) systems for tracking adverse events. Studies have shown that these systems, including the use of mobile apps, can improve the detection and management of side effects, potentially enhancing treatment outcomes and patient safety. The use of PRO systems like the Common Terminology Criteria for Adverse Events (CTCAE) and its electronic version (PRO-CTCAE) has been evaluated in various cancer treatment settings, demonstrating their feasibility and acceptability for monitoring symptoms and adverse events. ^{6 7 8 9 10}

Is the Outcomes4Me app a promising treatment for breast cancer?

Yes, the Outcomes4Me app is a promising treatment for breast cancer. It helps patients report their symptoms easily using their smartphones, which allows doctors to monitor their health more closely. This can lead to better symptom management and improve the quality of life for patients. ^{1 4 11 12 13}

Research Team

Jenni Sheng, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Study Team Member Exclusion Criteria: None

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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 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]

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]

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]

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 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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and accessibility of electronic patient-reported outcome measures using a smartphone during routine chemotherapy: a pilot study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Probing the benefits of real-time tracking during cancer care. [2022]

3. United States 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. [2022]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. [2022]

6. Canada 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

8. United States 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. [2023]

9. Germany 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. [2022]

10. United States 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. [2022]

11. Switzerland 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. [2022]

12. Canada 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. [2022]

13. United States 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. [2021]