Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05214144
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-31
First Post:
2022-01-13
Brief Title:
The In4M Study Integrating 4 Methods to Assess Physical Function in Cancer Patients
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
The In4M Study Integrating 4 Methods to Assess Physical Function in Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational cohort study Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic The Study Period is 9 months during which enrolled patients will use their personal smartphone computer or other web-connected device to connect with the Hugo platform which will deliver PRO questionnaires and sync to the wearable device in the study Fitbit The PerfO 6MWT will be conducted twice in clinic during the study period Structured information from the electronic health record EHR and patient portals will be collected and where needed the EHR will be directly reviewed to record AEs hospitalizationsemergency department visits and dose delayreductions Required in-person face to face visit is only at baseline for consent enrollment and receipt of wearable device patients can be followed remotely afterward ie do not need to be treated at Mayo or Yale
Detailed Description:
The purpose of this prospective observational study is to collect and evaluate 4 different sources of physical functioning PF data over the course of systemic anti-cancer therapy in lymphoma and breast cancer patients clinician-reported Performance Status PS Patient Reported Outcomes PROs a Performance Outcome PerfO and patient wearable device data
Aim 1 To measure PF using 4 distinct modalities ClinRo PRO PerfO and wearable device data on Hugo platform
Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
Report on trajectories of function as ascertained by the 4 PF modalities
Aim 2 To explore associations between various sources of physical function data and determine change thresholds
To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
Compare change over time in data within and between the PF modalities
Explore associations between changes in the various PF modalities and subsequent patient-reported adverse events AEs acute care use unplanned hospitalizations or emergency department visits other patient-reported domains of Health Related Quality of Life HRQOL and dose delayreduction
Aim 3 To assess patient acceptability and experience using the different PF assessment modalities
Administer an exit questionnaire to understand burden and usability of electronic PROs and wearable device data collection from the patient perspective
The allocation for patient recruitment is 18 months with 9 months for follow up for each patient The proposed overall project timeline is 35 years39 months A total of 200 patients will be enrolled at Yale Cancer Center and the Mayo Clinic as outlined below Data will be cleaned reviewed and analyzed as it is received from the Hugo platform on a rolling basis Data analysis will be conducted at Mayo Clinic and Yale Only de-identified data will be provided to the FDA
Aim 1 To measure PF using 4 distinct modalities ClinRo PRO PerfO and wearable device data on Hugo platform
Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
Report on trajectories of function as ascertained by the 4 PF modalities
Aim 2 To explore associations between various sources of physical function data and determine change thresholds
To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
Compare change over time in data within and between the PF modalities
Explore associations between changes in the various PF modalities and subsequent patient-reported adverse events AEs acute care use unplanned hospitalizations or emergency department visits other patient-reported domains of Health Related Quality of Life HRQOL and dose delayreduction
Aim 3 To assess patient acceptability and experience using the different PF assessment modalities
Administer an exit questionnaire to understand burden and usability of electronic PROs and wearable device data collection from the patient perspective
The allocation for patient recruitment is 18 months with 9 months for follow up for each patient The proposed overall project timeline is 35 years39 months A total of 200 patients will be enrolled at Yale Cancer Center and the Mayo Clinic as outlined below Data will be cleaned reviewed and analyzed as it is received from the Hugo platform on a rolling basis Data analysis will be conducted at Mayo Clinic and Yale Only de-identified data will be provided to the FDA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2U01FD005938-03 | FDA | None | httpsreporternihgovquickSearch2U01FD005938-03 |