Digital Symptom Tracking for Advanced Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-english speaking, Prostate cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tracking symptoms with an app can aid in managing advanced cancer care. Participants will use a web-based tool called Noona to regularly log their symptoms, potentially improving communication with healthcare providers and enhancing symptom management. The trial compares this digital approach to the usual care people receive. It suits those with advanced lung or gastrointestinal cancer who have access to a smartphone, tablet, or computer. As an unphased trial, this study offers a unique opportunity to contribute to innovative cancer care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on tracking symptoms rather than changing treatments.

What prior data suggests that this digital symptom tracking tool is safe for patients with advanced cancer?

Research has shown that the Noona web-based tool helps patients track symptoms and report side effects from cancer treatments. As a digital tool, not a medication or physical treatment, Noona is generally safe to use.

No reports indicate problems directly caused by using Noona. Instead, it enables patients to share symptoms more effectively with their healthcare team, potentially leading to better management of issues arising from cancer treatment. Overall, Noona aims to improve communication rather than raise safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Symptom Tracking for Advanced Cancer trial because it explores a new way to empower patients in managing their symptoms. Unlike traditional treatments that focus solely on medical interventions, the Noona web-based tool engages patients directly, allowing them to log and track their symptoms over six months. This real-time symptom tracking can lead to more personalized care, potentially improving communication with healthcare providers and enhancing the overall treatment experience. By integrating technology with patient care, this approach could transform how symptoms are monitored and managed in advanced cancer, offering a more proactive and patient-centered solution.

What evidence suggests that the Noona web-based symptom tracking tool is effective for advanced cancer?

Research has shown that the Noona web-based tool can help cancer patients manage their symptoms more effectively. In this trial, some participants will use the Noona tool alongside their usual care. Studies have found that Noona allows patients to report symptoms and side effects from home, enhancing communication with their healthcare team. For instance, a real-world study found that using Noona made it easier for patients to alert their doctors to serious symptoms. This regular symptom tracking can lead to faster responses from healthcare providers, potentially improving patient outcomes. Overall, Noona enables patients to take an active role in managing their health by staying connected with their care team. ^{1 2 3 4 6}

Who Is on the Research Team?

Kavitha Ramchandran, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a smartphone, tablet, or computer to use a symptom tracking app.

I am able to get out of my bed or chair and move around.

Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures

Exclusion Criteria

My prostate cancer responds to hormone therapy.

I am able to communicate in English.

Enrolled in other non-therapeutic or therapeutic clinical trials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Noona web-based symptom tracking tool to log symptoms weekly for 24 weeks

24 weeks

Weekly symptom logging via personal devices

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Use of Noona web-based symptom tracking tool

Trial Overview 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.

How Is the Trial Designed?

Group I: Noona web-based symptom tracking tool Experimental Treatment 1 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 Care Active Control 1 Intervention

Participants will receive the standard of care for their disease

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

The Advanced Symptom Management System (ASyMS) significantly reduced symptom burden in patients undergoing adjuvant chemotherapy, keeping their symptoms at pre-treatment levels, while those receiving standard care experienced increased symptoms throughout treatment.

Patients using ASyMS reported better quality of life and lower anxiety levels compared to the control group, indicating that remote monitoring can enhance patient support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). Maguire, R., McCann, L., Kotronoulas, G., 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]

An online platform for collecting patient-reported outcomes (PROs) in chemotherapy patients was found to be highly feasible, with 85% of patients using it during follow-up visits over 16 months, indicating strong acceptance and satisfaction from both patients and clinicians.

The system's alert feature effectively facilitated timely clinical responses, such as delaying treatments or modifying doses based on reported serious toxicities, potentially enhancing patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. Basch, E., Artz, D., Iasonos, A., et al.[2022]

Citations

1. varian.com varian.com/products/software/patient-engagement/noona

Noona Noona empowers patients to record their symptoms, respond to symptom and quality of life questionnaires sent by their care team, and get access to personalized ...

2. formative.jmir.org formative.jmir.org/2021/5/e16156

A Novel Digital Patient-Reported Outcome Platform (Noona ... Noona is an internet-based system for patients to self-report symptoms and adverse events of cancer treatments from home via a computer or a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05112198

Study Details | NCT05112198 | Digital Symptom Tracking, ... The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8138702/

A Novel Digital Patient-Reported Outcome Platform (Noona ... Noona is an internet-based system for patients to self-report symptoms and adverse events of cancer treatments from home via a computer or a smart device.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11773859/

Real-world ePRO use and clinical outcomes ... This ambispective observational study assessed the impact of Noona, an electronic patient-reported outcomes (ePRO) platform, for patients with non-small cell ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05112198

Digital Symptom Tracking, Patient Engagement and Quality ... The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences ...