Phase 3
Completed N=108
PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
Cancer · Lung Cancer · Gastro-intestinal
Source: ClinicalTrials.gov NCT04616768 ↗
Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)? — 4.5; 4.5 units on a scale
◆ Published Evidence
Emerging
16citations · ~8 / year
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.
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 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.
Linked Publications (4)
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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.
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Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial.
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Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.
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Derivation and External Validation of Objective Performance Status Among Patients With Metastatic Cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)? |
4.5; 4.5 | — |
| PRIMARY Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5) |
4.5; 4.3 | — |
| SECONDARY Additional Analysis of the Primary Outcome Between Arms |
4.5; 4.5; 4.4; 4.4; 4.5; 4.3 | — |
| SECONDARY Adherence |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04616768) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.