60 Participants NeededMy employer runs this trial

Digital Symptom Monitoring for Breast Cancer

KL
Overseen ByKimberley Lee
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
Must be taking: Oral endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with early-stage hormone receptor-positive breast cancer manage side effects from hormone therapy using a digital tool. Participants will either use a web-based symptom monitoring system (Digital Endocrine Therapy Symptom Monitoring and Education Intervention) or receive standard educational materials. The researchers aim to determine how effectively these tools help women adhere to their prescribed hormone treatments. Women who have recently started hormone therapy and have access to an internet-enabled phone may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require you to continue your hormone therapy. Other treatments like radiotherapy and certain targeted therapies are allowed.

What prior data suggests that this digital symptom monitoring intervention is safe for breast cancer patients?

Research has shown that using digital tools to monitor symptoms in patients receiving hormone therapy for breast cancer is generally safe. Studies have found that these tools, such as apps for tracking symptoms remotely, are easy for patients to use. No major side effects have been reported from these digital systems. They help patients track symptoms and improve communication with healthcare providers, leading to better management of any side effects from hormone therapy. Overall, these tools support patients without adding extra risks.12345

Why are researchers excited about this trial?

Researchers are excited about the Digital Endocrine Therapy Symptom Monitoring and Education Intervention because it introduces a novel way of managing symptoms through digital technology. Unlike traditional treatments that focus solely on medication, this intervention uses a web-based platform to actively monitor and educate patients about their symptoms. This approach empowers patients by providing real-time feedback and personalized education, potentially leading to better adherence to treatment and improved quality of life. Additionally, this method promotes patient engagement and self-management, which are crucial for long-term health outcomes.

What evidence suggests that this digital symptom monitoring intervention is effective for managing breast cancer therapy side-effects?

Research has shown that digital tools for tracking symptoms can assist individuals undergoing hormone therapy for breast cancer. In this trial, participants in ARM A will use a web-based symptom monitoring intervention. One study found that a symptom-tracking app improved quality of life and helped manage symptoms, even if it didn't affect medication adherence. Another study found that app-based tools reduced cancer-related symptoms, which can complicate daily life. Feedback from app users indicated they missed fewer doses and managed symptoms more actively. This evidence suggests that digital tools may help patients handle side effects and maintain their treatment regimen. Participants in ARM B will receive usual care, including an educational handout on endocrine therapy.678910

Who Is on the Research Team?

KL

Kimberley Lee, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with stage 0-III hormone receptor-positive breast cancer who have started oral hormone therapy within the last 16 weeks. Participants must be able to use an electronic pill bottle, speak English, and own a smartphone. Recent surgery or chemo must be completed at least two weeks before joining.

Inclusion Criteria

I finished chemotherapy at least 14 days ago.
* Capable of using the electronic pill bottle
I identify as a woman.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a web-based intervention for symptom monitoring and health promotion for endocrine therapy

48 weeks
Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Endocrine therapy Symptom Monitoring and Education Intervention

Trial Overview

The study tests a digital tool that helps women on hormone therapy for breast cancer track symptoms and get educational support using their smartphones. The goal is to see if this approach helps manage side effects and encourages sticking with treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ARM A InterventionExperimental Treatment1 Intervention
Group II: ARM B Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

Fox Chase Cancer Center

Collaborator

Trials
236
Recruited
39,300+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Remote Monitoring App for Endocrine Therapy Adherence ...

In this study, a remote monitoring app along with text messages did not change AET adherence but improved secondary outcomes, such as frequency ...

Symptom Monitoring App Use Associated With Medication ...

Overall, 163 women with early-stage HR+ breast cancer were included; 35.0% had high app use (≥75% of weeks enrolled). No sociodemographic ...

Developing a digital symptom monitoring intervention to ...

This intervention has great promise for reducing cancer-related symptoms burden which negatively impact quality of life and potentially improving breast cancer ...

Remote Monitoring App for Endocrine Therapy Adherence ...

Among patients with early-stage breast cancer who were prescribed AET, an app-based intervention with weekly symptom and adherence monitoring ...

Remote Monitoring App for Endocrine Therapy...

Our results showing fewer missed-dose alerts and more active symptom management among app plus feedback participants add to prior research ...

A Telehealth Intervention for Symptom Management, Distress ...

Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial ...

Remote Monitoring App for Endocrine Therapy Adherence ...

This randomized clinical trial assesses whether a remote monitoring app with or without additional weekly text messages improves adherence ...

Feasibility of Symptom Monitoring During the First Year ...

Feasibility of Symptom Monitoring During the First Year of Endocrine Therapy for Early Breast Cancer Using Patient-Reported Outcomes Collected ...

Alert-based patient-reported outcome monitoring improves ...

These investigators aimed to determine if a remote symptom monitoring program using electronic patient-reported outcomes improves fatigue among ...

Wearable Enhanced Fitness Tracking for Metastatic Breast ...

Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer ...