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OpenTrials
Completed

NCT Number: NCT05112198

Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer

The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management.

With the assistance of the study coordinator, participants randomized to the intervention will create an account with Noona. Patients will be instructed to log symptoms as often as relevant using their own personal devices. Patients will also be prompted once per week for 24 weeks to log any recent symptoms. These participants will be sent a Symptom Questionnaire (SQ) via the Noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the SQ will trigger a prompt to contact the clinical team for immediate follow-up.

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Key information

Conditions

Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cancer Institute, Palo Alto, California, United States

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About this study

New patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (Stanford and UCSF) will be screened for demographic and disease stage data within the patient medical record. Eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care.

Patients who express interest and ability to participate will be interviewed to determine eligibility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals (men and women) aged 18 years or older
  • Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
  • No limit on prior lines of therapy in the metastatic setting
  • ECOG performance status of 0-2
  • Estimated life expectancy of at least 6 months
  • Access to smartphone, tablet or computer with capability to utilize symptom tracking application
  • 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
  • Willing and able to comply with all study procedures

Exclusion criteria

  • Concurrent disease or condition that interferes with participation or safety
  • Non-english speaking, as the application is developed in the english language
  • Non-castrate resistant prostate cancer
  • Enrolled in other non-therapeutic or therapeutic clinical trials

Treatment and study plan

Use of Noona web- based symptom tracking tool

Other

Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress

Primary outcomes

  1. Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform

    Time frame: 6 months

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

    Time frame: baseline, 6 months

    Scores goes from (1-5). 5=Excellent and 1=Poor

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

    Time frame: baseline, 6 months

    Scores goes from (1-5). 5=Excellent and 1=Poor

Secondary outcomes

  1. Rate of SQ adherence

    Time frame: 6 months

    Rate of SQ adherence is defined as completing at least 70% of requested SQs

  2. Average number of diary encounters

    Time frame: 6 months

    A Noona system log in is recorded as a diary encounter

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

    Time frame: baseline, 6 months

    Scores goes from (0-4). 4=Very Much and 0=Not at all

  4. Symptom experience

    Time frame: 6 months

    Number of patient-reported symptoms by type and severity

  5. Proportion of clinicians that report satisfactory use of the Noona system

    Time frame: 6 months

  6. Tabulated responses from Noona Patient Feedback questionnaire

    Time frame: 6 months

    Questions include patient response to question about getting started with the Noona system and ease of use and user experience.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Noona Healthcare
  • Varian Medical Systems

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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