NCT05112198

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

October 27, 2021

Last Update Submit

March 24, 2026

Conditions

Quality of Life

Keywords

Patient and clinician engagementDigital Symptom Tracking

Outcome Measures

Primary Outcomes (3)

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

    6 months

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

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

    baseline, 6 months

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

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

    baseline, 6 months

Secondary Outcomes (6)

  • Rate of SQ adherence

    6 months

  • Average number of diary encounters

    6 months

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

    baseline, 6 months

  • Symptom experience

    6 months

  • Proportion of clinicians that report satisfactory use of the Noona system

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Noona web-based symptom tracking tool

EXPERIMENTAL

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.

Other: Use of Noona web- based symptom tracking tool

Usual Care

NO INTERVENTION

Participants will receive the standard of care for their disease

Interventions

Use of Noona web- based symptom tracking toolOTHER

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

Noona web-based symptom tracking tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

UCSF Helen Diller Medical Center

San Francisco, California, 94115, United States

Location

Study Officials

  • Kavitha Ramchandran, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CLINICAL ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

March 1, 2018

Primary Completion

August 23, 2024

Study Completion

August 23, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)