Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer (NCT05112198) | Clinical Trial Compass
CompletedNot Applicable
Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer
United States190 participantsStarted 2018-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform
Timeframe: 6 months
2
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score
Timeframe: baseline, 6 months
3
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score