AI Monitoring for Cancer Survivors

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart failure, Atrial fibrillation, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find a cost-effective way to monitor heart health in cancer survivors using AI technology. It focuses on individuals who have survived lymphoma or sarcoma and are either starting or have completed anthracycline therapy, a common cancer treatment. Participants will use a smartwatch (called WATCH) to track heart function and fitness levels, helping to detect early signs of heart problems. This trial suits those who have completed or are starting anthracycline treatment and can follow the study's procedures. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance heart health monitoring for future cancer survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this AI monitoring method is safe for cancer survivors?

Research has shown that wearable devices, such as smartwatches, are generally safe for tracking health information. One study demonstrated that smartwatches effectively monitored patients with brain cancer without causing harm. Another study found that these devices can detect health changes in cancer patients, enabling doctors to identify problems early.

Researchers have also discovered that smartwatches can track vital signs in cancer patients, helping to catch issues before they become serious. Overall, using a smartwatch to monitor health in cancer survivors, as the research suggests, typically does not lead to any side effects or risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI Monitoring for Cancer Survivors trial because it introduces a novel approach to monitoring heart health in lymphoma and sarcoma survivors. Unlike traditional follow-up care that might rely on periodic in-person check-ups, this trial uses an Apple Watch to continuously track ECG and cardio fitness data. This real-time monitoring allows for more immediate detection of heart issues, which is crucial for patients who have undergone anthracycline-based therapy, known to affect the heart. By employing technology for continuous data collection, this method aims to enhance patient outcomes and potentially prevent long-term cardiac complications.

What evidence suggests that this AI monitoring method is effective for cardiovascular surveillance in cancer survivors?

Research shows that wearable devices like the Apple Watch can help monitor the health of cancer survivors. In this trial, participants in the Longitudinal Arm can record ECG and cardio fitness data through an Apple Watch from before up to one year after anthracycline treatment. Studies have found that these smartwatches accurately track heart health and physical activity, which is crucial for those who have undergone cancer treatments. For example, researchers at the Cleveland Clinic discovered that data from smartwatches can help predict disease progression and identify complications. Additionally, using wearable activity trackers has been linked to better health outcomes, such as timely medication adherence and symptom tracking. This suggests that a smartwatch could effectively monitor heart health after cancer treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Joerg Herrmann, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

The WATCH trial is for cancer survivors, specifically those who have had sarcoma or lymphoma. Participants should be interested in long-term heart health monitoring using wearable technology like an Apple Watch and willing to undergo various tests such as ECGs, echocardiograms, and exercise assessments.

Inclusion Criteria

I understand and agree to follow the study's procedures.

I was diagnosed with lymphoma or sarcoma and started or completed anthracycline therapy within the last year.

Exclusion Criteria

Unwilling or unable to give written informed consent

Participants who have opted out of the Minnesota Research Authorization

My heart function is below normal, or I have a history of heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are monitored using AI-ECG and Apple Watch for cardiac function during and after anthracycline-based therapy

12 months

Every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• WATCH

Trial Overview This study is testing the effectiveness of AI-powered mobile devices and smartwatches in detecting heart problems in cancer survivors. It involves regular cardiovascular monitoring through non-invasive methods like wearables to prevent heart failure risks.

How Is the Trial Designed?

Group I: Longitudinal Arm Experimental Treatment 9 Interventions

Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.

Group II: Cross-sectional Arm Active Control 5 Interventions

Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352708/

Meta-Analysis of Randomized Controlled Trials - PMC Researchers from 21 studies assessed the effectiveness of WEDS-supported PA programs on the QoL of cancer survivors. The random-effects model ...

2. jmir.org jmir.org/2024/1/e51291/

Associations of Wearable Activity Tracker Use With ... This study aims to determine the association of wearable activity trackers with physical activity and health outcomes in patients with cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8323022/

Consumer Wearables and the Integration of New Objective ... Wearable research in oncology applications has demonstrated benefits, such as improved medication adherence and accuracy of symptom tracking, over self-reported ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/can-smartwatch-data-predict-progression-and-detect-complications-in-patients-with-glioblastoma

Can Smartwatch Data Help Monitor Patients With Glioblastoma? Cleveland Clinic researchers are harnessing the power of smartwatch data to predict disease progression in patients with glioblastoma.

5. vivosense.com vivosense.com/apple-digital-biomarker-outcomes

Evaluating Digital Biomarkers from Apple Watch Data to ... Explore how Apple Watch-derived digital biomarkers can transform cancer care by providing real-world insights into patient health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10887889/

Experiences with Wearable Sensors in Oncology during ... The aim of this case report is to describe the Danish research experience with wearable sensors in oncology reporting from three oncological wearable research ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666693622001517

Wearable device use and technology preferences in ... The purpose of this study was to understand technology usage and preferences in cancer survivors with or at risk for AF, and to describe demographic factors ...

8. emjreviews.com emjreviews.com/oncology/article/wearable-devices-for-vital-sign-monitoring-in-hematology-and-oncology-patients-an-integrative-review-of-implementation-barriers-and-detection-performance-j330124/

Wearable Devices for Vital Sign Monitoring in Hematology ... Wearable devices offer continuous vital sign monitoring for hospitalized hematology and oncology patients, potentially enabling earlier detection of associated ...