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| ID | Type | Description | Link |
|---|---|---|---|
| R37CA242545 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
Participants will:
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) via an anonymous Qualtrics survey link embedded in the app and opened in their smartphone's internet browser. 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 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. Reports will be automatically generated and emailed each week displaying their summarized data and a list of all the individual data points that triggered alerts which they can then share with their care team, family members, etc. Weekly reports will include a link to an optional survey asking for feedback on how they've used the last week's report. 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, about any communication with their cancer care team since their last survey, and approximately how much time they spent each day on tasks related to cancer care.
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 7-10 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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Patient-Reported Outcome Measurement Information System (PROMIS) 29+2 is used to evaluate general health-related quality of life. The seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) have four items per domain and use a 5-point Likert response scale. Possible range of scores for these 7 domains is 4 to 20. The pain intensity item uses a numeric rating scale (0 [no pain] to 10 [worst pain imaginable]). The sum of raw scores for each domain is converted into a standardized T-score using a publicly available conversion table or an online scoring service. Higher scores represent worse symptoms for symptom-oriented domains (anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance) and better health outcomes for function-oriented domains (physical functioning and ability to participate in social roles and activities). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carissa A Low | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
Preliminary IPD data from this pilot study will not be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2026 | Jul 2, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Change from baseline to the end of the intervention (at approximately 90 days) |
| Change from baseline to the end of the intervention (at approximately 90 days) |
| Depressive symptoms | Center for Epidemiologic Studies Depression Scale (CES-D Scale). Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Objective physical activity | A Bluetooth enabled activity monitor worn throughout the study will estimate number of steps/day. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Activity disruption | Sickness Impact Profile short form (6 items) is used to assess a person's perception of their health status with respect to their disease impact. Possible range of scores is 0 (0%) to 6 (100%). Higher scores represent poor health status or a major impact of illness on behavior. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Instrumental Support | PROMIS Instrumental Support v2.0 - Short Form 4a is 4-item short form assessing perceived availability of assistance with material, cognitive or task performance. Responses are rated on a 5-point Likert scale, yielding a total score range of 4 to 16. Higher scores indicate greater perceived instrumental support. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Self-Efficacy for Managing Symptoms | PROMIS Self-Efficacy for Managing Symptoms v1.0 - Short Form 4a is a 4-item short form assessing confidence to manage/control symptoms, to manage symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships, or recreational activities. Responses are rated on a 5-point Likert scale, yielding a total score range of 4 to 16. Higher scores indicate greater perceived self-efficacy for managing symptoms. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Short Physical Performance Battery (SPPB) | The SPPB is a short battery of performance tests of lower extremity functioning. The tests measure gait speed, standing balance, and lower extremity strength and power. To test gait speed, patients are instructed to walk an 8-foot walking course at their usual pace with assistive devices if needed. Four progressively more challenging positions are used to test balance (bipedal [feet next to each other], semi-tandem [one foot slightly in front of the other], and full tandem [one foot in front of the other]). To test lower extremity strength, patients are asked to stand up and sit down five times as quickly as possible and are timed from the initial sitting position to the final standing position at the end of the fifth stand. Each component (gait speed, balance, chair stands) is scored 0-4, where 0 is unable to complete task and 4 indicates highest level of performance. Total score is 0-12 with higher scores indicating better lower extremity function. | Change from baseline to the end of the intervention (at approximately 90 days) |
| Patient-Centered Communication Questionnaire - Cancer | The PCC-Ca-36 is a 36-item questionnaire to assess patients' experience with patient-centered communication during cancer care. It evaluates 6 core functions: exchanging information, fostering healing relationships, making decisions, attention to emotions, taking care of yourself, and dealing with uncertainty. Responses are rated on a 5-point Likert scale with some items having the option "Does not apply". Individual functions are scored by averaging items within the function and an overall PCC score is the average of all items. Higher scores indicate better perceived patient-centered communication. | Change from baseline to the end of the intervention (at approximately 90 days) |