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

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

November 19, 2020

Primary Completion Date

December 17, 2021

Study Completion Date

December 17, 2021

Conditions
CancerLung CancerGastro-intestinal
Interventions
OTHER

PRO questionnaire

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

OTHER

Step monitoring

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.

OTHER

Active nudge text feedback

"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.)."

OTHER

PROStep Dashboard (clinicians)

"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"

Trial Locations (1)

19104

Perelman Center for Advanced Medicine (PCAM), Philadelphia

All Listed Sponsors
lead

Abramson Cancer Center at Penn Medicine

OTHER

NCT04616768 - PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers | Biotech Hunter | Biotech Hunter