Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

NCT07218874 | Recruiting

• 2 other identifiers: STUDY25070088R37CA242545
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

quality of life; symptom management; smartphone application

Outcome Measures

Primary Outcomes (5)

• Acceptability via semi-structured interviews

  Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the program (e.g., likelihood to keep using app and to recommend app)

  At the end of the intervention (at approximately 90 days)

• Acceptability via System Usability Scale

  System Usability Scale (SUS). For odd items, subtract one from the user response. For even-numbered items, subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. Possible range of scores is 0 to 100 representing a composite measure of the overall usability of the system being studied.

  At the end of the intervention (at approximately 90 days)

• Feasibility via accrual rate

  accrual rate (number of participants that enroll \[consent and provide at least one form of data\] out of number of participants approached)

  From enrollment to the end of the intervention (at approximately 90 days)

• Feasibility via engagement

  engagement (how many days within the study the participants engaged with the app and had Fitbit data)

  From enrollment to the end of the intervention (at approximately 90 days)

• Feasibility via completion rate

  completion rate (number of participants that complete the study)

  From enrollment to the end of the intervention (at approximately 90 days)

Secondary Outcomes (1)

• Patient-Reported Physical Symptoms

  Change from baseline to the end of the intervention (at approximately 90 days)

Other Outcomes (8)

• Quality of Life

  Change from baseline to the end of the intervention (at approximately 90 days)

• Depressive symptoms

  Change from baseline to the end of the intervention (at approximately 90 days)

• Objective physical activity

  Change from baseline to the end of the intervention (at approximately 90 days)

Study Arms (1)

Symptom monitoring via smartphone app

EXPERIMENTAL

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.

Behavioral: Mobile Symptom Monitoring and Alert App

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.

Symptom monitoring via smartphone app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving chemotherapy at the UPMC Hillman Cancer Center for any solid tumor cancer at any stage with at least two cycles remaining;
• age 18 years or older;
• ability to read and write in English;
• sufficient performance status to participate in research (e.g., Karnofsky performance status of 60-100%); and
• owns and uses an Android smartphone or an iPhone capable of running the study apps.

You may not qualify if:

• under 18 years old; and
• unable to read and write in English

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Carissa A Low

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carissa A Low

CONTACT

(412) 623-5973; lowca@upmc.edu

Krina C Durica

CONTACT

duricak@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)