Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07218874
Status
Recruiting
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Conditions

  • Cancer
  • Chemotherapy
  • Solid Tumor Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mobile Symptom Monitoring and Alert App — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Symptom monitoring via smartphone app
    Participants will rate symptoms daily for 90 days using PRO-CATCAE questions to assess 8 common chemotherapy-related symptoms. Participants will wear a Fitbit (Inspire 3 or similar) for the duration of the study and install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server.

Primary Outcome Measure

Acceptability via semi-structured interviews [ Time Frame: At the end of the intervention (at approximately 90 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Carissa A Low
[email protected]
(412) 623-5973
Carissa A Low (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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