Monitoring symptoms in breast cancer patients using a smartphone app

SMART-ER: A Pilot Study to Assess the Feasibility of Symptom Monitoring With Patient-reported Outcomes Collected Via Smart Phone App in Patients With Estrogen and/or Progesterone Receptor-positive Stage I-III Breast Cancer at Risk for Adjuvant Endocrine Therapy Non-adherence or Early Discontinuation

This study is testing a smartphone app to help women with hormone receptor-positive breast cancer track their symptoms and treatment progress while starting hormone therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Washington, District of Columbia and 1 other locations)
• Trial ID: NCT05560685 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of using the Outcomes4Me smartphone app to collect patient-reported outcome (PRO) surveys from women with hormone receptor-positive breast cancer who are about to start adjuvant endocrine therapy. Participants will complete surveys at baseline and at intervals of 2, 4, 8, and 12 weeks after therapy initiation to track symptoms, treatment adherence, and quality of life. The goal is to enhance symptom management and support adherence to therapy by detecting symptoms early through regular reporting. The study will also assess the impact of financial hardship on treatment adherence and the effectiveness of symptom management interventions.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with stage I-III hormone receptor-positive invasive breast cancer who are planning to start adjuvant endocrine therapy.

Not a fit: Patients who have already initiated adjuvant endocrine therapy or those with other types of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve symptom management and treatment adherence for breast cancer patients undergoing endocrine therapy.

How similar studies have performed: Other studies have shown promise in using patient-reported outcomes to improve treatment adherence and symptom management, indicating that this approach is both relevant and potentially effective.

Eligibility criteria

* Inclusion Criteria:
* Female
* Age ≥ 18 years
* Able to read and understand English.
* Histologically confirmed stage I-III hormone receptor-positive invasive breast carcinoma. Hormone receptor positivity is defined as estrogen receptor and/or progesterone receptor ≥ 1% on any core biopsy or surgical specimen.
* Must be planning to initiate adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor within the next 12 weeks. Patients are not eligible if they have already initiated adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor at the time of consent.
* Concurrent ovarian suppression with a luteinizing hormone releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) analog is allowed.
* Concurrent radiation therapy is allowed.
* Concurrent human epidermal growth factor receptor 2 (HER2)-targeted therapy is allowed.
* Completed all planned diagnostic and therapeutic breast and axillary surgical procedures.
* Must have an iPhone operating system (iOS - Apple iPhone) or Android smart phone that they are able to use and download the Outcomes4Me app on.
* Must have ability to access the internet via their smart phone.
* Must be planning to receive follow-up medical oncology care at the study site for the duration of the study. Patients seen for second opinion consultation who do not intend to follow-up at the study site for the duration of the study are not eligible to participate.
* In addition to the above stated criteria, in order to be eligible to participate in this study, an individual must meet at least one of the following criteria associated with higher risk for endocrine therapy non-adherence and/or non-persistence:
* Age ≤40 years OR age ≥ 70 years.
* Self-identify as Black, African American or African.
* On medication for depression and/or anxiety.
* At least one of the following comorbid health conditions (mark all that apply):

  * Congestive heart failure
  * Valvular disease
  * Pulmonary circulation disorder
  * Peripheral vascular disorder
  * Hypertension
  * Paralysis
  * Neurodegenerative disorder/Dementia
  * Chronic pulmonary disease
  * Diabetes
  * Hypothyroid
  * Renal disease
  * Liver disease
  * Peptic ulcer disease
  * Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection
  * Rheumatoid arthritis/collagen vascular disease
  * Coagulopathy
  * Obesity
  * Weight loss
  * Fluid/electrolyte disorder
  * Anemia
  * Alcohol abuse
  * Drug abuse
  * Psychosis
  * Depression
* Self-report one or more symptom of at least moderate severity, defined as ≥ 4 on a 0-10 point scale.

Study Team/Clinical Team Member Inclusion Criteria

* In order to be eligible to participate in this study, an individual must meet all of the following 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.

Exclusion Criteria:

* Patients who have previously received tamoxifen and/or an aromatase inhibitor are not eligible to participate.
* Patients initiating endocrine therapy for chemoprevention for high risk disease such as lobular carcinoma in situ, ductal carcinoma in situ, atypical ductal hyperplasia and/or atypical lobular hyperplasia in the absence of invasive breast carcinoma are not eligible to participate.
* Receipt of chemotherapy is not allowed during study participation. Patients may have received chemotherapy prior to study participation in the study.
* Concurrent treatment with adjuvant abemaciclib is not allowed during study participation.
* Concurrent treatment with adjuvant olaparib is not allowed during study participation.
* Patients may not receive any investigational agent as part of a therapeutic clinical trial during participation in this study. Patients who previously received an investigational agent as part of a therapeutic trial and who are in follow-up for the other therapeutic trial may participate in this trial.
* Patients may not participate in another trial evaluating an intervention to support endocrine therapy adherence and/or persistence during participation in this study.
* Patients may not participate in another trial evaluating an intervention to monitor or manage symptoms during participation in this study.

Study Team Member Exclusion Criteria

* None

Where this trial is running

Washington, District of Columbia and 1 other locations

• Sibley Memorial Hospital — Washington, District of Columbia, United States (Recruiting)
• Johns Hopkins — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Jenni Sheng, MD — Johns Hopkins University
• Study coordinator: Grace Mberekpe

Conditions Breast Cancer