PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
NCT ID: NCT04616768
Last Updated: 2025-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2020-11-19
2021-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm A - Control
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.
No interventions assigned to this group
Arm B - Intervention without text feedback
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.
PRO questionnaire
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 monitoring
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.
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
Arm C - Intervention with text feedback
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.
PRO questionnaire
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 monitoring
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 feedback
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)
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
Interventions
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PRO questionnaire
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 monitoring
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 feedback
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)
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
Eligibility Criteria
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Inclusion Criteria
2. Have a diagnosis of incurable or Stage IV lung or gastrointestinal cancer
3. 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)
4. Currently receiving or planned receipt within 2 weeks of IV chemotherapy (see exclusions below)
5. The patient has a smart phone that can receive SMS text messages and has blue-tooth capability that can connect to Fitbit.
Exclusion Criteria
2. 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)
3. Patients who are receiving checkpoint inhibitor monotherapy or oral tyrosine kinase inhibitors
4. 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.
5. Lung cancer patients enrolled in an ongoing palliative care clinical trial that may lead to better communication regarding symptoms and functional status.
6. Clinician concerns about behavioral health issues that may prevent engagement with text message prompts
7. 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)
18 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Ravi Parikh, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, United States
Countries
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References
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Manz 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.
Parikh 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.
Parikh 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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843616
Identifier Type: OTHER
Identifier Source: secondary_id
UPCC 27921
Identifier Type: -
Identifier Source: org_study_id
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