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Quality of LifeNCT05112198

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

A study testing Use of Noona web- based symptom tracking tool in people with Quality of Life, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life
What is being tested?
Use of Noona web- based symptom tracking tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
2 sitesUnited States
Study dates
1 Mar 2018to 23 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Stanford Cancer Institute

    Palo Alto, California, 94305

  • UCSF Helen Diller Medical Center

    San Francisco, California, 94115

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Quality of Life
Being tested
Use of Noona web- based symptom tracking tool
Keywords
Patient and clinician engagement, Digital Symptom Tracking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Noona web- based symptom tracking toolOther

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

Study groups in NCT05112198
Study groupRoleWhat they receive
Noona web-based symptom tracking toolExperimentalIn 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.
Receives: Other: Use of Noona web- based symptom tracking tool
Usual CareNo interventionParticipants will receive the standard of care for their disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

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

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

    Measured: baseline, 6 months

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

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

    Measured: baseline, 6 months

Secondary outcomes (6)

  1. Rate of SQ adherence

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

    Measured: 6 months

  2. Average number of diary encounters

    A Noona system log in is recorded as a diary encounter

    Measured: 6 months

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

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

    Measured: baseline, 6 months

  4. Symptom experience

    Number of patient-reported symptoms by type and severity

    Measured: 6 months

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

    Measured: 6 months

  6. Tabulated responses from Noona Patient Feedback questionnaire

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start1 Mar 2018
  3. Primary completion23 Aug 2024
  4. Study completion23 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112198
Sponsor's protocol ID
IRB-38423
Other IDs
NCI-2021-12414
Status last verified
Mar 2026
First submitted
27 Oct 2021
Last updated
30 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Use of Noona web- based symptom tracking tool in people with Quality of Life, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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