Clinical trial NCT04616768: PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Lung Cancer
Gastro-intestinal
Keywords: activity
patient-reported outcomes
GI
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. English-speaking
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:

1. Age \< 18 years
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)

Primary outcomes:
measure: Patient perceptions of symptom management
timeFrame: 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:
measure: Additional analysis of the primary outcome between arms
timeFrame: These will be measured at 3 months after enrollment for each patient.
measure: Adherence
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Comparison of PRO scores (Arms B and C)
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Fitbit step data
timeFrame: Each patient will be enrolled in the trial for a total of six months.
Other outcomes:
measure: Number of palliative care consults (exploratory)
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Number of documented advanced care planning (ACP) notes (exploratory)
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Number of documented serious illness conversations (SIC) (exploratory)
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Correlation between step, heart rate, distance, pace, elevation and sleep data trends, patient reported outcomes, patient and clinician ECOG assessment, and patient hospitalization and survival (exploratory)
timeFrame: Each patient will be enrolled in the trial for a total of six months.
measure: Patient utility surveys (exploratory)
timeFrame: Each patient will be surveyed at 3 and 6 months following enrollment.
measure: Clinician utility surveys (exploratory)
timeFrame: Each patient will be surveyed at 3 and 6 months following enrollment.
measure: Additional analysis of the primary outcome between different arms (6 month) (exploratory)
timeFrame: These will be measured at 6 months (or 3 months if the patient did not complete their 6 month survey) after enrollment for each patient.
measure: Additional analysis of the primary outcome between different arms (3 month) (exploratory)
timeFrame: These will be measured at 3 months after enrollment for each patient.
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine (PCAM)
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ravi Parikh, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.