Digital Symptom Tracking for Advanced Cancer

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

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Noona web-based symptom tracking tool for advanced cancer?

Research shows that digital tools for symptom tracking, like the Noona tool, can help manage symptoms early by allowing patients to report them systematically. Studies have found that electronic patient-reported outcome measures (ePROMs) can improve the assessment of symptoms like pain and anxiety, which are often underrated by healthcare staff, leading to better supportive care. ^{1 2 3 4 5}

Is digital symptom tracking safe for cancer patients?

Research shows that digital symptom tracking tools, like the Noona web-based tool, are generally safe for cancer patients. Studies have found high levels of patient and clinician satisfaction, and these tools can help manage symptoms effectively without causing harm. ^{2 6 7 8 9}

How is digital symptom tracking unique for advanced cancer treatment?

Digital symptom tracking for advanced cancer is unique because it uses technology like tablets and remote monitoring to collect patient-reported symptoms in real-time, which helps healthcare providers manage symptoms more effectively and improve communication with patients. This approach is different from traditional treatments that may not involve systematic, real-time data collection from patients. ^{1 2 3 5 8}

Research Team

Kavitha Ramchandran, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer patient-reported outcomes assessment using wireless touch screen tablet computers. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and User Experience of Digital Patient Monitoring for Real-World Patients With Lung or Breast Cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Electronic Patient-Reported Outcome Measures (ePROMs) Improve the Assessment of Underrated Physical and Psychological Symptom Burden among Oncological Inpatients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Extending computer technology to hospice research: interactive pentablet measurement of symptoms by hospice cancer patients in their homes. [2021]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. [2022]