CompletedPhase 3

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

United States108 participantsStarted 2020-11-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Exclusion criteria

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

What they're measuring

Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?

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)

Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)

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)

Trial details

NCT IDNCT04616768

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-17

Results submitted2024-08-19

View on ClinicalTrials.gov More Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Exclusion criteria

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

What they're measuring

Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?

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)

Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)

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)