CancerROSA AppNCT07218874
Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application
A study testing Mobile Symptom Monitoring and Alert App in people with Cancer and Solid Tumor Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor Cancer, Chemotherapy
- What is being tested?
- Mobile Symptom Monitoring and Alert App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- under 18 years old; and
- unable to read and write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
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?
Read more
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).
Read the 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) 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.
- Conditions
- Cancer, Solid Tumor Cancer, Chemotherapy
- Being tested
- Mobile Symptom Monitoring and Alert App
- Keywords
- quality of life, symptom management, smartphone application
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Symptom Monitoring and Alert AppBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Symptom Monitoring and Alert App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrollment to the end of the intervention (at approximately 90 days)
Secondary outcomes (1)
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.
Measured: Change from baseline to the end of the intervention (at approximately 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start2 Feb 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carissa Low, University of Pittsburgh
- Investigators
- Carissa A Low, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218874
- Sponsor's protocol ID
- STUDY25070088
- Other IDs
- R37CA242545
- Acronym
- ROSA App
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Preliminary IPD data from this pilot study will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application
- ClinicalTrials.gov ID
- NCT07218874
- Acronym / sponsor ID
- ROSA App / STUDY25070088
- Conditions
- Cancer, Solid Tumor Cancer, Chemotherapy
- Keywords
- quality of life, symptom management, smartphone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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) 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom monitoring via smartphone app | Experimental | Behavioral: Mobile Symptom Monitoring and Alert AppParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- under 18 years old; and
- unable to read and write in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Symptom Monitoring and Alert AppResponses 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. | Behavioural | Symptom monitoring via smartphone app |
Primary outcome
Acceptability via semi-structured interviews
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of the intervention (at approximately 90 days)
completion rate (number of participants that complete the study)
1 secondary outcome
Patient-Reported Physical Symptoms
Time frame: Change from baseline to the end of the intervention (at approximately 90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Preliminary IPD data from this pilot study will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carissa A Low principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Symptom Monitoring and Alert App in people with Cancer and Solid Tumor Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability via semi-structured interviews (time frame: At the end of the intervention (at approximately 90 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.