CancerPhase 3PROStepNCT04616768
PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
A Phase 3 study testing PRO questionnaire, Step monitoring and Active nudge text feedback in people with Cancer and Lung Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Telemedicine allows clinicians to utilize modern telecommunication technology to provide healthcare services to patients including remote symptom monitoring. Given the spread of COVID-19 both locally and globally, is crucial to adapt accordingly in order to safely provide vulnerable cancer patient populations with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer, Gastro-intestinal
- What is being tested?
- PRO questionnaire, Step monitoring and Active nudge text feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 17 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English-speaking
- Have a diagnosis of incurable or Stage IV lung or gastrointestinal cancer
- Receive primary oncology care with a thoracic or gastrointestinal medical oncology specialist at the Perelman Center for Advanced Medicine (i.e. does not have a local oncologist that provides cancer care, including other UPHS clinic sites)
- Currently receiving or planned receipt within 2 weeks of IV chemotherapy (see exclusions below)
- The patient has a smart phone that can receive SMS text messages and has blue-tooth capability that can connect to Fitbit.
Who cannot join
- Age < 18 years
- Patients has used a wheelchair, been bedbound or is unable to walk without assistance from other people every day for the past 7 days (patients are not excluded for the use of walkers or canes)
- Patients who are receiving checkpoint inhibitor monotherapy or oral tyrosine kinase inhibitors
- Patients who receive chemotherapy infusions at another UPHS site or outside of UPHS or whose primary oncologist is not in thoracic or gastrointestinal oncology groups at PCAM. Notably, patients who receive part of their chemotherapy regimen at home will still be allowed to enroll.
- Lung cancer patients enrolled in an ongoing palliative care clinical trial that may lead to better communication regarding symptoms and functional status.
- Clinician concerns about behavioral health issues that may prevent engagement with text message prompts
- Are enrolled in another interventional clinical trial (as clinical trials often have a substantial symptom-reporting structure; non-interventional clinical trials are permitted e.g. trials that just involve blood tests)
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Feasibility Trial Using Remote Patient-reported Outcomes and Wearable Technology-reported Step Data to Compare Engagement, Utilization, and Functional Status in Patients With Incurable Lung and Gastrointestinal Cancers
Telemedicine allows clinicians to utilize modern telecommunication technology to provide healthcare services to patients including remote symptom monitoring. Given the spread of COVID-19 both locally and globally, is crucial to adapt accordingly in order to safely provide vulnerable cancer patient populations with optimal care while minimizing risk of exposure to COVID-19. In this study, the investigators will utilize remote monitoring of patients with cancer via weekly patient-reported outcome (PRO) collection through the Way to Health (W2H) smartphone application and step data through wearable Fitbit devices. Patients with incurable lung and gastrointestinal cancers will be recruited based on whether they receive their care in-clinic or remotely. They will respond to weekly phone-based symptom surveys and wear Fitbits that track step data. This data will be collated in a Palliative Care Assessment Dashboard (PROStep Dashboard) sent to clinicians prior to each oncology visit to help inform patient management. In this feasibility study, two arms of patients will be monitored with symptom surveys and Fitbits; the study will randomize these patients to either 1) receive text feedback or 2) receive no text feedback. A third arm of patients will be randomized to receive no feedback, symptom surveys, or Fitbit device. Clinicians for patients in each arm will receive the PROstep Dashboard. The study will determine feasibility of this monitoring approach, and compare patient adherence to symptom surveys and step data collection between the two intervention arms.
- Conditions
- Cancer, Lung Cancer, Gastro-intestinal
- Being tested
- PRO questionnaire, Step monitoring, Active nudge text feedback, PROStep Dashboard (clinicians)
- Keywords
- activity, patient-reported outcomes, GI
- Medical subject headings
- Neoplasms, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO questionnaireOther
These text message surveys will inquire about seven symptoms, requesting a response rating the patient's response. The seven symptoms have been selected by lung and GI oncology clinicians at PCAM from a list of twelve validated symptoms from the National Cancer Institute's Common Terminology Criteria for Adverse Events and will be scored on a five point scale from 0 (no present) to 4 (disabling). The patients will also receive a question asking about their activity level over the prior month
Step monitoringOther
A CRC will provide patients with a Fitbit at enrollment and instruct them on how to wear the Fitbit device and periodically sync the device with their phone which will send updated step data to the research team.
Active nudge text feedbackOther
Intervention patients in arm c will receive text feedback describing worsening or severe symptoms collected from their remote PRO questionnaires (i.e. "Your following symptoms are severe or have gotten worse:") and their step count ("Your Fitbit step count compared to last week is worse."). They will also receive an "active nudge" question on their upcoming visit (i.e. "Do you plan on discussing these symptoms with your oncologist at your upcoming visit? Type "1" if you plan to discuss them; Type "2" if you do not plan to discuss them.").
PROStep Dashboard (clinicians)Other
The study team will provide an updated PROStep Dashboard to lung or GI oncology clinicians for each patient enrolled in the intervention arms prior to their appointments. W2H will generate the dashboards and the study team will physically deliver it to their office or touchdown space or send electronically. The Dashboard will include:
- Home-based PRO report, including the weekly survey results for each question in tabular and graphical form
- Step data report, including a summary of number of daily steps in graphical form (with rolling weekly averages) and weekly averages in tabular form
- A list of all acute care utilization in the UPHS system in the prior 6 months including Oncology Evaluation Unit visits, Emergency department visits, Inpatient admissions
- Whether the patient has had an outpatient palliative care visit
- Whether the patient has had a documented Serious Illness Conversation
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Control | No intervention | An arm of ≤42 patients will not receive PRO surveys, a Fitbit device, or patient feedback texts messages. They will receive shortened utility surveys at 3 and 6 months following enrollment, but their clinicians will not receive dashboards or utility surveys. |
| Arm B - Intervention without text feedback | Experimental | An arm of ≤42 patients enrolled intervention patients will be randomized to receive weekly patient-reported outcome questionnaires, be given Fitbits to monitor weekly step counts and utility surveys at 3 and 6 months following enrollment. Their clinicians will receive a "PROStep Dashboard" prior to their appointments and utility surveys at 3 and 6 months. Receives: Other: PRO questionnaire; Other: Step monitoring; Other: PROStep Dashboard (clinicians) |
| Arm C - Intervention with text feedback | Experimental | An arm of ≤42 patients enrolled intervention patients will be randomized to receive weekly patient-reported outcome questionnaires, be given Fitbits to monitor weekly step counts and utility surveys at 3 and 6 months following enrollment. Their clinicians will receive a "PROStep Dashboard" prior to their appointments and utility surveys at 3 and 6 months. Patients in this arm will receive an additional text prior to appointments that summarizes their symptoms and incorporates an active nudge question. Receives: Other: PRO questionnaire; Other: Step monitoring; Other: Active nudge text feedback; Other: PROStep Dashboard (clinicians) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?
Patient utility surveys will use a 5-point Likert scale for responses scored 1-5. The two co-primary outcomes will compare the scores for the following two questions, measured at 6 months (or 3 months if the patient did not complete their 6 month survey), between intervention patients (Arms B + C) and control patients (Arm A).
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.
Measured: These will be measured at 6 months after enrollment for each patient (or 3 months if the patient did not complete their 6 month survey)
Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)
Patient utility surveys will use a 5-point Likert scale for responses scored 1-5. The two co-primary outcomes will compare the scores for the following two questions, measured at 6 months (or 3 months if the patient did not complete their 6 month survey), between intervention patients (Arms B + C) and control patients (Arm A).
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.
Measured: These will be measured at 6 months after enrollment for each patient (or 3 months if the patient did not complete their 6 month survey)
Secondary outcomes (2)
Additional Analysis of the Primary Outcome Between Arms
The following secondary outcome will compare the same questions measured at 3 months, between intervention patients (Arms B + C) and control patients (Arm A).
- Q1 - How well do you feel your oncology team understands your symptoms (e.g. nausea, vomiting, weight loss, etc.)? (1-5)
- Q2 - How well do you feel your oncology team understands your activity level and ability to function? (1-5)
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.
Measured: These will be measured at 3 months after enrollment for each patient.
Adherence
We will compare cumulative adherence for patients in the intervention group (arm B and arm C). Each week, adherence will be defined as each week where the patient submits the weekly survey (i.e. adherence to PRO) and has step data for 4 of 7 days of the week (i.e. adherence to Fitbit platform), divided by the total number of weeks that the patient is enrolled in the trial.
- Comparison of mean patient adherence at three months for patients in arm B vs arm C
- Comparison of mean patient adherence at six months for patients in arm B vs arm C
Measured: Each patient will be enrolled in the trial for a total of six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start19 Nov 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Parikh, MD, MPP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616768
- Sponsor's protocol ID
- UPCC 27921
- Other IDs
- 843616
- Acronym
- PROStep
- Status last verified
- Jun 2025
- First submitted
- 16 Oct 2020
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz E, Manz CR, Girard A, Hernandez-Guerrero T, Doger De-Speville B, Morillo D, Mahillo-Fernandez I, Garcia-Foncillas J, Li E, Ferrell WJ, Barnett I, Moreno V, Parikh RB. Derivation and External Validation of Objective Performance Status Among Patients With Metastatic Cancer. JCO Oncol Pract. 2026 Mar;22(3):400-409. doi: 10.1200/OP-25-00195. Epub 2025 Jul 25.
PubMed 40712112Manz CR, Schriver E, Ferrell WJ, Williamson J, Wakim J, Khan N, Kopinsky M, Balachandran M, Chen J, Patel MS, Takvorian SU, Shulman LN, Bekelman JE, Barnett IJ, Parikh RB. Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial. J Med Internet Res. 2024 May 17;26:e51059. doi: 10.2196/51059.
PubMed 38758583Parikh RB, Schriver E, Ferrell WJ, Wakim J, Williamson J, Khan N, Kopinsky M, Balachandran M, Gabriel PE, Schuchter LM, Patel MS, Shulman LN, Manz CR. Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1143-1151. doi: 10.1200/OP.23.00048. Epub 2023 Oct 10.
PubMed 37816198Parikh RB, Ferrell W, Wakim J, Williamson J, Khan N, Kopinsky M, Balachandran M, Gabriel PE, Zhang Y, Schuchter LM, Shulman LN, Chen J, Patel MS, Manz CR. Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial. BMJ Open. 2022 May 12;12(5):e054675. doi: 10.1136/bmjopen-2021-054675.
PubMed 35551088
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial Using Remote Patient-reported Outcomes and Wearable Technology-reported Step Data to Compare Engagement, Utilization, and Functional Status in Patients With Incurable Lung and Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT04616768
- Acronym / sponsor ID
- PROStep / UPCC 27921
- Conditions
- Cancer, Lung Cancer, Gastro-intestinal
- Keywords
- activity, patient-reported outcomes, GI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Telemedicine allows clinicians to utilize modern telecommunication technology to provide healthcare services to patients including remote symptom monitoring. Given the spread of COVID-19 both locally and globally, is crucial to adapt accordingly in order to safely provide vulnerable cancer patient populations with optimal care while minimizing risk of exposure to COVID-19. In this study, the investigators will utilize remote monitoring of patients with cancer via weekly patient-reported outcome (PRO) collection through the Way to Health (W2H) smartphone application and step data through wearable Fitbit devices. Patients with incurable lung and gastrointestinal cancers will be recruited based on whether they receive their care in-clinic or remotely. They will respond to weekly phone-based symptom surveys and wear Fitbits that track step data. This data will be collated in a Palliative Care Assessment Dashboard (PROStep Dashboard) sent to clinicians prior to each oncology visit to help inform patient management. In this feasibility study, two arms of patients will be monitored with symptom surveys and Fitbits; the study will randomize these patients to either 1) receive text feedback or 2) receive no text feedback. A third arm of patients will be randomized to receive no feedback, symptom surveys, or Fitbit device. Clinicians for patients in each arm will receive the PROstep Dashboard. The study will determine feasibility of this monitoring approach, and compare patient adherence to symptom surveys and step data collection between the two intervention arms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A - Control | No intervention | –An arm of ≤42 patients will not receive PRO surveys, a Fitbit device, or patient feedback texts messages. They will receive shortened utility surveys at 3 and 6 months following enrollment, but their clinicians will not receive dashboards or utility surveys. |
| Arm B - Intervention without text feedback | Experimental | Other: PRO questionnaire, Other: Step monitoring, Other: PROStep Dashboard (clinicians)An arm of ≤42 patients enrolled intervention patients will be randomized to receive weekly patient-reported outcome questionnaires, be given Fitbits to monitor weekly step counts and utility surveys at 3 and 6 months following enrollment. Their clinicians will receive a "PROStep Dashboard" prior to their appointments and utility surveys at 3 and 6 months. |
| Arm C - Intervention with text feedback | Experimental | Other: PRO questionnaire, Other: Step monitoring, Other: Active nudge text feedback, Other: PROStep Dashboard (clinicians)An arm of ≤42 patients enrolled intervention patients will be randomized to receive weekly patient-reported outcome questionnaires, be given Fitbits to monitor weekly step counts and utility surveys at 3 and 6 months following enrollment. Their clinicians will receive a "PROStep Dashboard" prior to their appointments and utility surveys at 3 and 6 months. Patients in this arm will receive an additional text prior to appointments that summarizes their symptoms and incorporates an active nudge question. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English-speaking
- Have a diagnosis of incurable or Stage IV lung or gastrointestinal cancer
- Receive primary oncology care with a thoracic or gastrointestinal medical oncology specialist at the Perelman Center for Advanced Medicine (i.e. does not have a local oncologist that provides cancer care, including other UPHS clinic sites)
- Currently receiving or planned receipt within 2 weeks of IV chemotherapy (see exclusions below)
- The patient has a smart phone that can receive SMS text messages and has blue-tooth capability that can connect to Fitbit.
Key exclusion criteria (7 listed)
- Age < 18 years
- Patients has used a wheelchair, been bedbound or is unable to walk without assistance from other people every day for the past 7 days (patients are not excluded for the use of walkers or canes)
- Patients who are receiving checkpoint inhibitor monotherapy or oral tyrosine kinase inhibitors
- Patients who receive chemotherapy infusions at another UPHS site or outside of UPHS or whose primary oncologist is not in thoracic or gastrointestinal oncology groups at PCAM. Notably, patients who receive part of their chemotherapy regimen at home will still be allowed to enroll.
- Lung cancer patients enrolled in an ongoing palliative care clinical trial that may lead to better communication regarding symptoms and functional status.
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 |
|---|---|---|
| PRO questionnaireThese text message surveys will inquire about seven symptoms, requesting a response rating the patient's response. The seven symptoms have been selected by lung and GI oncology clinicians at PCAM from a list of twelve validated symptoms from the National Cancer Institute's Common Terminology Criteria for Adverse Events and will be scored on a five point scale from 0 (no present) to 4 (disabling). The patients will also receive a question asking about their activity level over the prior month | Other | Arm B - Intervention without text feedback, Arm C - Intervention with text feedback |
| Step monitoringA CRC will provide patients with a Fitbit at enrollment and instruct them on how to wear the Fitbit device and periodically sync the device with their phone which will send updated step data to the research team. | Other | Arm B - Intervention without text feedback, Arm C - Intervention with text feedback |
| Active nudge text feedbackIntervention patients in arm c will receive text feedback describing worsening or severe symptoms collected from their remote PRO questionnaires (i.e. "Your following symptoms are severe or have gotten worse:") and their step count ("Your Fitbit step count compared to last week is worse."). They will also receive an "active nudge" question on their upcoming visit (i.e. "Do you plan on discussing these symptoms with your oncologist at your upcoming visit? Type "1" if you plan to discuss them; Type "2" if you do not plan to discuss them."). | Other | Arm C - Intervention with text feedback |
| PROStep Dashboard (clinicians)The study team will provide an updated PROStep Dashboard to lung or GI oncology clinicians for each patient enrolled in the intervention arms prior to their appointments. W2H will generate the dashboards and the study team will physically deliver it to their office or touchdown space or send electronically. The Dashboard will include: 1. Home-based PRO report, including the weekly survey results for each question in tabular and graphical form 2. Step data report, including a summary of number of daily steps in graphical form (with rolling weekly averages) and weekly averages in tabular form 3. A list of all acute care utilization in the UPHS system in the prior 6 months including Oncology Evaluation Unit visits, Emergency department visits, Inpatient admissions 4. Whether the patient has had an outpatient palliative care visit 5. Whether the patient has had a documented Serious Illness Conversation | Other | Arm B - Intervention without text feedback, Arm C - Intervention with text feedback |
Primary outcome
Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?
Time frame: These will be measured at 6 months after enrollment for each patient (or 3 months if the patient did not complete their 6 month survey)
Patient utility surveys will use a 5-point Likert scale for responses scored 1-5. The two co-primary outcomes will compare the scores for the following two questions, measured at 6 months (or 3 months if the patient did not complete their 6 month survey), between intervention patients (Arms B + C) and control patients (Arm A). Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.
Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)
Time frame: These will be measured at 6 months after enrollment for each patient (or 3 months if the patient did not complete their 6 month survey)
Patient utility surveys will use a 5-point Likert scale for responses scored 1-5. The two co-primary outcomes will compare the scores for the following two questions, measured at 6 months (or 3 months if the patient did not complete their 6 month survey), between intervention patients (Arms B + C) and control patients (Arm A). Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.
2 secondary outcomes
Additional Analysis of the Primary Outcome Between Arms
Time frame: These will be measured at 3 months after enrollment for each patient.
Adherence
Time frame: Each patient will be enrolled in the trial for a total of six months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40712112Ruiz E, Manz CR, Girard A, Hernandez-Guerrero T, Doger De-Speville B, Morillo D, Mahillo-Fernandez I, Garcia-Foncillas J, Li E, Ferrell WJ, Barnett I, Moreno V, Parikh RB. Derivation and External Validation of Objective Performance Status Among Patients With Metastatic Cancer. JCO Oncol Pract. 2026 Mar;22(3):400-409. doi: 10.1200/OP-25-00195. Epub 2025 Jul 25.
- Derived from this study: PubMed 38758583Manz CR, Schriver E, Ferrell WJ, Williamson J, Wakim J, Khan N, Kopinsky M, Balachandran M, Chen J, Patel MS, Takvorian SU, Shulman LN, Bekelman JE, Barnett IJ, Parikh RB. Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial. J Med Internet Res. 2024 May 17;26:e51059. doi: 10.2196/51059.
- Derived from this study: PubMed 37816198Parikh RB, Schriver E, Ferrell WJ, Wakim J, Williamson J, Khan N, Kopinsky M, Balachandran M, Gabriel PE, Schuchter LM, Patel MS, Shulman LN, Manz CR. Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1143-1151. doi: 10.1200/OP.23.00048. Epub 2023 Oct 10.
- Derived from this study: PubMed 35551088Parikh RB, Ferrell W, Wakim J, Williamson J, Khan N, Kopinsky M, Balachandran M, Gabriel PE, Zhang Y, Schuchter LM, Shulman LN, Chen J, Patel MS, Manz CR. Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial. BMJ Open. 2022 May 12;12(5):e054675. doi: 10.1136/bmjopen-2021-054675.
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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.
Ravi Parikh, MD, MPP principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRO questionnaire, Step monitoring and Active nudge text feedback in people with Cancer and Lung Cancer, run by Abramson Cancer Center at Penn Medicine 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 7 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 2 Jul 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)? (time frame: These will be measured at 6 months after enrollment for each patient (or 3 months if the patient did not complete their 6 month survey)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616768, which also lists 4 linked publications.
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 2 Jul 2025.