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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Quality of Life

Intervention / Treatment
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* Device: Use of Noona web- based symptom tracking tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient and clinician engagement, Digital Symptom Tracking