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NCT04616768 · ClinicalTrials.gov registry record · Phase 3
PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
A Phase 3 study of Cancer and Lung Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT04616768: Completed Phase 3 study of Cancer and Lung Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
NCT04616768 is a Phase 3 study of Cancer and Lung Cancer that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 108 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616768, a Phase 3 study of Cancer and Lung Cancer, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER PRO questionnaire
- OTHER Step monitoring
- OTHER Active nudge text feedback
- OTHER PROStep Dashboard (clinicians)
Study Locations (1)
Pennsylvania
- Perelman Center for Advanced Medicine (PCAM) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 3 |
What the finished NCT04616768 record still lists
NCT04616768 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which PRO questionnaire is the first listed.
NCT04616768 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04616768 about?
NCT04616768 is a clinical study titled "PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI 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 p...
What is the current status of trial NCT04616768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2020-11-19. Estimated completion is 2021-12-17.
What conditions does trial NCT04616768 study?
This clinical trial studies the following conditions: Cancer, Lung Cancer, Gastro-intestinal.
What interventions are being tested in trial NCT04616768?
The interventions under investigation include: PRO questionnaire (OTHER), Step monitoring (OTHER), Active nudge text feedback (OTHER), PROStep Dashboard (clinicians) (OTHER).
Who is sponsoring clinical trial NCT04616768?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616768 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04616768's enrollment target sits among peer trials
108 307th of 615 higher than 308 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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