Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application
NCT07218874 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-04
Summary
The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are:
* Is the mobile application feasible and acceptable to patients?
* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?
Participants will:
* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.
* Complete daily symptom ratings.
* Wear a Fitbit activity tracker for 90 days.
* At the end of the study, complete a semi-structured interview to provide feedback on the study.
* Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).
Conditions
- Cancer
- Solid Tumor Cancer
- Chemotherapy
Interventions
- BEHAVIORAL
-
Mobile Symptom Monitoring and Alert App
Responses range from 0-4; any grade 1 response (reflecting mild symptoms) will trigger a recommendation to view symptom management/education tips available in a self-care library in the app, and any grade 2-4 response (reflecting moderate to severe symptoms) will trigger a recommendation that the participant may want to contact their provider about the potentially concerning symptom. Fitbit data points outside of prespecified thresholds based on physiological norms (for skin temperature and pulse oxygenation) or each participants' historic average (heart rate and activity) will trigger a recommendation that the participant may want to contact their provider about the potentially concerning data point. Reports will be generated and emailed to participants each week displaying summaries/graphs of recent alerts triggered, symptom ratings, and Fitbit data.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Carissa A Low · University of Pittsburgh
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-02
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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