Trial Outcomes & Findings for PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers (NCT NCT04616768)

Last Updated: 2025-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome 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)

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A - Control 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 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. 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 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. 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.	Arm C - Intervention With Text Feedback 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. 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 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. Active nudge text feedback: Arm C patients will receive a text describing worsening or severe symptoms collected from their remote PRO questionnaires and their step count and an "active nudge" question. PROStep Dashboard (clinicians)
Overall Study STARTED	33	37	38
Overall Study COMPLETED	31	24	25
Overall Study NOT COMPLETED	2	13	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Control n=33 Participants 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 n=37 Participants 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. 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 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. 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.	Arm C - Intervention With Text Feedback n=38 Participants 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. 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 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. Active nudge text feedback: Arm C patients will receive a text describing worsening or severe symptoms collected from their remote PRO questionnaires and their step count and an "active nudge" question. PROStep Dashboard (clinicians)	Total n=108 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	59 years n=7 Participants	57 years n=5 Participants	59 years n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	59 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other/Declined to identify	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	25 Participants n=5 Participants	30 Participants n=7 Participants	32 Participants n=5 Participants	87 Participants n=4 Participants
Symptoms Poorly controlled	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Symptoms Well-controlled	29 Participants n=5 Participants	35 Participants n=7 Participants	31 Participants n=5 Participants	95 Participants n=4 Participants
Symptoms Prefer not to answer	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Education HS/GED	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Education Some college	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Education Vocational	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Education Associate	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Education Bachelor	13 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	42 Participants n=4 Participants
Education Postgraduate	8 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Text Frequency 3-5 times weekly	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Text Frequency Nearly every day	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Text Frequency Multiple times every day	29 Participants n=5 Participants	31 Participants n=7 Participants	32 Participants n=5 Participants	92 Participants n=4 Participants

PRIMARY outcome

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)

Population: We originally were going to compare arms A v. B v. C, but due to lower-than-anticipated enrollment and higher-than-expected mortality, this was modified before the completion of the follow-up period and any data analysis to compare the control arm (A) with the combined intervention arms (B + C). The combined intervention was deemed to be more clinically relevant since we did not believe that responses to the symptom understanding question would be meaningfully different between Arms B and C.

Outcome measures

Outcome measures
Measure	Arm A n=31 Participants Control	Arms B+C n=49 Participants Intervention	Arm C - Intervention With Text Feedback 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. 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 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. Active nudge text feedback: Arm C patients will receive a text describing worsening or severe symptoms collected from their remote PRO questionnaires and their step count and an "active nudge" question. PROStep Dashboard (clinicians)
Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?	4.5 units on a scale Standard Deviation 1	4.5 units on a scale Standard Deviation 1	—

PRIMARY outcome

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)

Outcome measures

Outcome measures
Measure	Arm A n=31 Participants Control	Arms B+C n=49 Participants Intervention	Arm C - Intervention With Text Feedback 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. 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 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. Active nudge text feedback: Arm C patients will receive a text describing worsening or severe symptoms collected from their remote PRO questionnaires and their step count and an "active nudge" question. PROStep Dashboard (clinicians)
Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)	4.5 units on a scale Standard Deviation .9	4.3 units on a scale Standard Deviation 1	—

SECONDARY outcome

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

The following secondary outcome will compare the same questions measured at 3 months, between intervention patients (Arms B + C) and control patients (Arm A). * Q1 - How well do you feel your oncology team understands your symptoms (e.g. nausea, vomiting, weight loss, etc.)? (1-5) * Q2 - How well do you feel your oncology team understands your activity level and ability to function? (1-5) Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely.