Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

Not Applicable

Not yet recruiting

• Conditions: Cancer; Solid Tumor Cancer; Chemotherapy

• Registration Number: NCT07218874
• Lead Sponsor: University of Pittsburgh

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 via study application.

* 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).

Detailed Description

Participants (n=50) will be recruited from UPMC Hillman clinics.

If eligible patients consent to participate, they will complete online baseline, midpoint, and end of study questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will be linked only to their study ID number.

Following informed consent, participants will have the ROSA Android or iOS application installed on their smartphones that are capable of running the app (or will be talked through the installation of the app on their smartphone if conducting visit remotely). The application will securely store this information on the device and transmit this information to a secure cloud-based research server over secure network (WiFi or cellular) connection at least once per day. All data will be de-identified and will use only a study ID number linked to identifying participant information in a password protected file. The data captured for the research will not include any personally identifiable information. The data plan requirements of the application are not significantly different from what most smartphone users would require if they use their device to access the Internet for web searching.

At the initial visit (either in person or online, 20-30 minutes), participants will also be oriented to the ecological momentary assessment procedures to assess patient-reported symptoms. Participants will install the ROSA Android or iOS application on their smartphones. The unique non-identifying participant ID will be entered into the app upon initial log in and will be saved locally on the device. This code number will be attached to participant data so that the research team will be able to know which participant code number each survey response is associated with. Participants will be able to set the time of day for which they wish to receive notifications to complete the daily symptom ratings. When participants receive the survey notification, it will open up the study application and they can proceed to take the daily survey (approximately 5 minutes) in the ROSA app on their smartphone. Symptoms will be assessed using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE).

Participants will be asked to complete at least one rating per day and will report on symptoms over the last 24 hours. Responses range from 0-4; any grade 1 response (reflecting mild symptoms) will trigger symptom management/education tips to be shown (which are also available to view anytime 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. Participants will also be able to generate data reports from within the ROSA app that show summaries/graphs of recent alerts triggered, symptom ratings, and Fitbit data, and they can then share these data reports with their care team, family members, etc. In addition to the PRO-CTCAE questions in the daily survey, participants will also be asked to rate their overall quality of life for that day from 0 (worst possible) to 10 (best possible), about any cancer treatment they've received since the last survey, and about any communication with their cancer care team since their last survey.

As feasible, participants will complete the Short Physical Performance Battery (SPPB) at the UPMC Hillman Cancer Center or the research team's office at baseline and at the end of the study. During these visits, this in-person assessment will be administered by trained study team members. Participants that enroll in the study remotely will be invited to complete the in-person SPPB as feasible. The SPPB will be conducted within 2 weeks of the enrollment date and within 2 weeks of the end of study date.

Participants will also be asked to wear a Fitbit device as feasible (Fitbit Inspire 3 or similar) for the duration of the study and to 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. Participants will be asked to charge the device as needed, approximately every 4-5 days. If they already own a Fitbit device that collects comparable data to the study provided device, we will request access to their Fitbit data for the duration of their study participation. Fitbit data points exceeding prespecified thresholds based on physiological norms (for skin temperature and pulse oxygenation) or each participants' historic average (heart rate and activity) will trigger follow-up questions and, depending on responses, a recommendation that the participant may want to contact their provider about the potentially concerning data point.

At the end of the study, we will assist participants in removing the ROSA app from their phones. Participants will also complete an end of study interview at this time.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-16
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Study Start: 2025-11-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability via semi-structured interviews	At the end of the intervention (at approximately 90 days)	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)
Acceptability via System Usability Scale	At the end of the intervention (at approximately 90 days)	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.
Feasibility via accrual rate	From enrollment to the end of the intervention (at approximately 90 days)	accrual rate (number of participants that enroll \[consent and provide at least one form of data\] out of number of participants approached)
Feasibility via engagement	From enrollment to the end of the intervention (at approximately 90 days)	engagement (how many days within the study the participants engaged with the app and had Fitbit data)
Feasibility via completion rate	From enrollment to the end of the intervention (at approximately 90 days)	completion rate (number of participants that complete the study)

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Physical Symptoms	Change from baseline to the end of the intervention (at approximately 90 days)	Symptoms will be assessed using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE; Dueck et al., 2015). PRO-CTCAE questions will assess eight symptoms common during chemotherapy for cancer, including decreased appetite, diarrhea, fatigue, nausea, neuropathy, pain, shortness of breath, and vomiting. The daily PRO-CTCAE questions include conditional branching where participants will not be asked about the severity, frequency, and/or the extent to which a symptom interfered with their activities if they do not endorse that symptom. Participants will be asked to complete at least one rating per day and will report on symptoms over the last 24 hours. Responses range from 0-4, with higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States