What is the mechanism of action of this treatment?

Web-based symptom self-monitoring and real-time symptom tracking, as studied in the Noona trial, work by enabling patients to regularly log and monitor their symptoms using digital tools. This approach allows for timely identification and management of symptoms, which can lead to prompt medical interventions and adjustments in treatment plans. By actively involving patients in their own care, these methods can improve patient engagement, adherence to treatment, and overall symptom control. This proactive management is crucial for enhancing the Quality of Life in patients, as it helps in reducing symptom burden, improving functional status, and providing a sense of control over their health.

What side effects are associated with this type of intervention?

Web-based symptom self-monitoring and real-time symptom tracking, such as those studied in the Noona trial, generally have minimal physical side effects. However, potential challenges include digital literacy barriers, data privacy concerns, and the need for consistent patient engagement. Some patients may experience anxiety or stress related to constant symptom tracking and the potential for frequent alerts. Additionally, technical issues such as software glitches or internet connectivity problems can impact the effectiveness of these interventions.

What prior FDA approvals exist?

The FDA has approved various digital health tools aimed at improving Quality of Life (QoL) for patients with chronic conditions. These include mobile apps and web-based platforms for symptom tracking and real-time management, similar to the Noona tool used in the study for advanced cancer patients. These digital interventions often facilitate better patient-clinician communication, timely symptom management, and personalized care plans, ultimately enhancing patient engagement and QoL. Examples include apps for diabetes management, mental health monitoring, and chronic pain management, which have shown efficacy in clinical trials and received FDA clearance.

What other types of research exist?

Promising alternatives to Noona for 2024 include: 1) MyChart by Epic Systems, which offers comprehensive patient engagement and real-time symptom tracking integrated with electronic health records. 2) HealthLoop, which provides automated follow-up and symptom monitoring with real-time alerts to clinicians. 3) Careology, a digital health platform designed for cancer patients that includes symptom tracking, medication reminders, and direct communication with healthcare providers. 4) Kaiku Health, which specializes in digital symptom tracking and patient-reported outcomes for oncology patients, offering personalized support and real-time data sharing with clinicians.

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Digital Symptom Tracking for Advanced Cancer

N/A

Waitlist Available

Led By Kavitha Ramchandran, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves cancer patients using the Noona app to log their symptoms. The app helps track symptoms and alerts patients to contact their clinical team if severe symptoms occur. This approach aims to improve symptom management and patient care. Noona is an internet-based system for patients to report symptoms and adverse events of cancer treatments from home.

Who is the study for?

This trial is for adults over 18 with advanced lung or gastrointestinal cancer, who can use a smartphone, tablet, or computer. They should be able to perform daily activities (ECOG status 0-2), have no limit on previous treatments in the metastatic setting, and are expected to live at least another 6 months. Non-English speakers and those with conditions that could interfere with participation or safety are excluded.

What is being tested?

The study tests the Noona web-based symptom tracking tool's impact on patient engagement and quality of life. Participants will log symptoms regularly using their devices and complete a Symptom Questionnaire before oncology visits for real-time symptom management over a period of 24 weeks.

What are the potential side effects?

Since this trial involves digital symptom tracking rather than medication or invasive procedures, there aren't typical side effects associated with drugs. However, participants may experience stress or anxiety from regular self-monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score

Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score

Secondary study objectives

Average number of diary encounters

Change in overall Functional Assessment of Cancer Therapy-General (FACT-G) score

Rate of SQ adherence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Noona web-based symptom tracking toolExperimental Treatment1 Intervention

In addition to usual care for their disease, patients interact with Noona system and system questioners to record their symptoms over a period of 6 months.

Group II: Usual CareActive Control1 Intervention

Participants will receive the standard of care for their disease

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Web-based symptom self-monitoring and real-time symptom tracking, as studied in the Noona trial, work by enabling patients to regularly log and monitor their symptoms using digital tools. This approach allows for timely identification and management of symptoms, which can lead to prompt medical interventions and adjustments in treatment plans. By actively involving patients in their own care, these methods can improve patient engagement, adherence to treatment, and overall symptom control. This proactive management is crucial for enhancing the Quality of Life in patients, as it helps in reducing symptom burden, improving functional status, and providing a sense of control over their health.