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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Other: Use of Noona web- based symptom tracking tool

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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Cancer Institute
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals (men and women) aged 18 years or older
2. Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
3. No limit on prior lines of therapy in the metastatic setting
4. ECOG performance status of 0-2
5. Estimated life expectancy of at least 6 months
6. Access to smartphone, tablet or computer with capability to utilize symptom tracking application
7. 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
8. Willing and able to comply with all study procedures

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noona web-based symptom tracking tool; 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; Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress
No Intervention: Usual Care; Participants will receive the standard of care for their disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of SQ adherence	Rate of SQ adherence is defined as completing at least 70% of requested SQs	6 months
Average number of diary encounters	A Noona system log in is recorded as a diary encounter	6 months
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	baseline, 6 months
Symptom experience	Number of patient-reported symptoms by type and severity	6 months
Proportion of clinicians that report satisfactory use of the Noona system		6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Varian Medical Systems; Noona Healthcare
• Investigators: Principal Investigator: Kavitha Ramchandran, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Patient and clinician engagement; Digital Symptom Tracking
• Other Study ID Numbers: IRB-38423; NCI-2021-12414 (Other Identifier: National Cancer Institute Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No