PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers

NCT04616768 | Completed Phase 3 Results

• 2 other identifiers: UPCC 27921843616
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Lung Cancer; Gastro-intestinal

Keywords

activity; patient-reported outcomes; GI

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  These will be measured at 3 months after enrollment for each patient.

• Adherence

  Each patient will be enrolled in the trial for a total of six months.

Other Outcomes (8)

• Number of Palliative Care Consults (Exploratory)

  Each patient will be enrolled in the trial for a total of six months.

• Number of Documented Advanced Care Planning (ACP) Notes (Exploratory)

  Each patient will be enrolled in the trial for a total of six months.

• Number of Documented Serious Illness Conversations (SIC) (Exploratory)

  Each patient will be enrolled in the trial for a total of six months.

Study Arms (3)

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.

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.

Other: PRO questionnaire; Other: Step monitoring; Other: Active nudge text feedback; Other: PROStep Dashboard (clinicians)

Interventions

PRO questionnaire OTHER

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

Arm B - Intervention without text feedback; Arm C - Intervention with text feedback

Step monitoring OTHER

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.

Arm B - Intervention without text feedback; Arm C - Intervention with text feedback

Active nudge text feedback OTHER

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.").

Arm C - Intervention with text feedback

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: 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 B - Intervention without text feedback; Arm C - Intervention with text feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• The patient has a smart phone that can receive SMS text messages and has blue-tooth capability that can connect to Fitbit.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Perelman Center for Advanced Medicine (PCAM)

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 38758583 DERIVED

• 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.

  PMID: 37816198 DERIVED

• 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.

  PMID: 35551088 DERIVED

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Behavior

Results Point of Contact

• Title: Ravi Parikh
• Organization: University of Pennsylvania

ravi.parikh@pennmedicine.upenn.edu

3524224285

Study Officials

• Ravi Parikh, MD, MPP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 5, 2020
• Study Start: November 19, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Locations

US (1)