Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

ConditionsCancer Solid Tumor Cancer Chemotherapy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Pittsburgh

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

under 18 years old; and

unable to read and write in English

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Symptom monitoring via smartphone appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

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.

Time frame

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)

Time frame

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)

Time frame

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

Secondary outcomes

Patient-Reported Physical Symptoms

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.

Time frame