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| ID | Type | Description | Link |
|---|---|---|---|
| 843616 | Other Identifier | UPenn IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Analysis of the Primary Outcome Between Arms | The following secondary outcome will compare the same questions measured at 3 months, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Parikh, MD, MPP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine (PCAM) | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40712112 | Derived | Ruiz E, Manz CR, Girard A, Hernandez-Guerrero T, Doger De-Speville B, Morillo D, Mahillo-Fernandez I, Garcia-Foncillas J, Li E, Ferrell WJ, Barnett I, Moreno V, Parikh RB. Derivation and External Validation of Objective Performance Status Among Patients With Metastatic Cancer. JCO Oncol Pract. 2026 Mar;22(3):400-409. doi: 10.1200/OP-25-00195. Epub 2025 Jul 25. | |
| 38758583 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm B - Intervention Without Text Feedback |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2021 |
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| 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. |
|
| 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."). |
|
| 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:
|
|
| These will be measured at 3 months after enrollment for each patient. |
| Adherence | We will compare cumulative adherence for patients in the intervention group (arm B and arm C). Each week, adherence will be defined as each week where the patient submits the weekly survey (i.e. adherence to PRO) and has step data for 4 of 7 days of the week (i.e. adherence to Fitbit platform), divided by the total number of weeks that the patient is enrolled in the trial.
| 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. |
| 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) | Each patient will be enrolled in the trial for a total of six months. |
| Patient Utility Surveys (Exploratory) | The utility to patients is measured using survey data at 3 and 6 months. These use a 5-point Likert Scale (1-5). We will report descriptive statistics for this data (mean and standard deviation) followed by t-tests between each individual arm and between all intervention patients (Arms B + C) and control patients (Arm A). | Each patient will be surveyed at 3 and 6 months following enrollment. |
| Clinician Utility Surveys (Exploratory) | The utility to clinicians will be measured using survey data at three and six months. These similarly use a 5-point Likert scale (1-5) and we will report descriptive statistics for this survey data. | Each patient will be surveyed at 3 and 6 months following enrollment. |
| Additional Analysis of the Primary Outcome Between Different Arms (6 Month) (Exploratory) | The following exploratory outcomes will make the following comparisons for responses to the two questions in the primary outcomes: o Measured at 6 months (or 3 months if the patient did not complete their 6 month survey)
Questions:
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 (or 3 months if the patient did not complete their 6 month survey) after enrollment for each patient. |
| Additional Analysis of the Primary Outcome Between Different Arms (3 Month) (Exploratory) | The following exploratory outcomes will make the following comparisons for responses to the two questions in the primary outcomes: o Measured at 3 months
Questions:
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely. | These will be measured at 3 months after enrollment for each patient. |
| 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. |
| 37816198 | 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. |
| 35551088 | 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. |
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. |
| FG002 | 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) |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Symptoms | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||
| Text Frequency | Participants were asked "Generally, how often do you send/receive text messages?" on their enrollment questionnaire. Responses included: a. Not at all b. Fewer than 3 times weekly c. 3-5 times weekly d. Nearly every day e. Multiple times every day | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| ||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 | Additional Analysis of the Primary Outcome Between Arms | The following secondary outcome will compare the same questions measured at 3 months, 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. | Posted | Mean | Standard Deviation | units on a scale | These will be measured at 3 months after enrollment for each patient. |
| |||||||||||||||||||||||||||||||
| Secondary | Adherence | We will compare cumulative adherence for patients in the intervention group (arm B and arm C). Each week, adherence will be defined as each week where the patient submits the weekly survey (i.e. adherence to PRO) and has step data for 4 of 7 days of the week (i.e. adherence to Fitbit platform), divided by the total number of weeks that the patient is enrolled in the trial.
| Not Posted | Each patient will be enrolled in the trial for a total of six months. | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Palliative Care Consults (Exploratory) | Not Posted | Each patient will be enrolled in the trial for a total of six months. | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Documented Advanced Care Planning (ACP) Notes (Exploratory) | Not Posted | Each patient will be enrolled in the trial for a total of six months. | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Documented Serious Illness Conversations (SIC) (Exploratory) | Not Posted | Each patient will be enrolled in the trial for a total of six months. | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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) | Not Posted | Each patient will be enrolled in the trial for a total of six months. | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient Utility Surveys (Exploratory) | The utility to patients is measured using survey data at 3 and 6 months. These use a 5-point Likert Scale (1-5). We will report descriptive statistics for this data (mean and standard deviation) followed by t-tests between each individual arm and between all intervention patients (Arms B + C) and control patients (Arm A). | Not Posted | Each patient will be surveyed at 3 and 6 months following enrollment. | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Clinician Utility Surveys (Exploratory) | The utility to clinicians will be measured using survey data at three and six months. These similarly use a 5-point Likert scale (1-5) and we will report descriptive statistics for this survey data. | Not Posted | Each patient will be surveyed at 3 and 6 months following enrollment. | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Additional Analysis of the Primary Outcome Between Different Arms (6 Month) (Exploratory) | The following exploratory outcomes will make the following comparisons for responses to the two questions in the primary outcomes: o Measured at 6 months (or 3 months if the patient did not complete their 6 month survey)
Questions:
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely. | Not Posted | 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. | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Additional Analysis of the Primary Outcome Between Different Arms (3 Month) (Exploratory) | The following exploratory outcomes will make the following comparisons for responses to the two questions in the primary outcomes: o Measured at 3 months
Questions:
Likert scale responses are defined as: 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely. | Not Posted | These will be measured at 3 months after enrollment for each patient. | Participants |
6 months
CRC chart review
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 33 | 0 | 33 | 0 | 33 |
| EG001 | 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. | 7 | 37 | 0 | 37 | 0 | 37 |
| EG002 | 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) | 2 | 38 | 0 | 38 | 0 | 38 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravi Parikh | University of Pennsylvania | 3524224285 | ravi.parikh@pennmedicine.upenn.edu |
| Dec 22, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Other/Declined to identify |
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| White |
|
| Well-controlled |
|
| Prefer not to answer |
|
| Some college |
|
| Vocational |
|
| Associate |
|
| Bachelor |
|
| Postgraduate |
|
| Nearly every day |
|
| Multiple times every day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | 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) |
|
|