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Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05390827
Collaborator
University of California, Los Angeles (Other)
3,096
Enrollment
1
Location
11.4
Anticipated Duration (Months)
271.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a secure method of collecting physiologic information from patients with cancer. The researchers will use this information to learn more about how physiologic data may relate to cancer diagnosis and response to treatment, and to identify factors that may lead to higher or lower risk of cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Project 1: HealthKit This prospective registry cohort study will aim to recruit a total of 3,000 patients. The targeted patient cohorts / settings will be (n=1000/cohort): (1) pre-treatment / during adjuvant therapy: patients with newly diagnosed early-stage solid tumors that are either pre- or during adjuvant therapy, (2) post-treatment: patients who completed definitive adjuvant therapy, and (3) metastatic setting: patients diagnosed with metastatic (stage IV) disease. This study will accrue patients receiving care at any MSK site.

    Project 2: DigIT-Ex This prospective registry cohort study will aim to recruit a total of 84 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort): (1) patients scheduled to undergo bone marrow transplantation, (2) patients newly diagnosed with acute myeloid leukemia (AML), (3) patients scheduled to undergo surgery for localized prostate cancer (4) patients scheduled to undergo surgery for lung cancer, (5) patients scheduled to undergo total neoadjuvant therapy for advanced rectal cancer, (6) patients scheduled to undergo antiandrogen therapy for advanced prostate cancer, and (7) patients scheduled to undergo chemotherapy for metastatic pancreatic cancer. The targeted adults without a history of cancer cohorts will be (n=12/cohort): (8) individuals without a history of cancer aged less than 50 years, and (9) individuals without a history of cancer aged greater than or equal to 50 years.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3096 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol
    Actual Study Start Date :
    May 19, 2022
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer [1 year]

      to create a repository and infrastructure to address novel questions of clinical importance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Project 1: HealthKit

    • Individuals who meet one of the following criteria:

    • Diagnosis of new onset early-stage (I-III) solid tumor within 12 months of initial recruitment approach (Cohort 1: Pre-treatment / during adjuvant therapy)

    • Diagnosis of primary invasive solid tumor from 2015 onwards (Cohort 2: Post-definitive adjuvant treatment)

    • Diagnosis of new onset metastatic (stage IV) solid tumor within 12 months of initial recruitment approach (Cohort 3: Metastatic setting)

    • 18 to 90 years old

    • Own an Apple iPhone with valid iOS operating software

    • Have the MyMSK app downloaded on their iPhone or be willing to download the MyMSK app

    • Willing to provide informed consent

    Project 2: DigIT-Ex

    Individuals who meet one of the following criteria:

    • Patients at MSK who are:

    • Scheduled to undergo any type of BMT (Cohort 1)

    • Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort

    • Scheduled to undergo any surgery for prostate cancer (Cohort 3)

    • Scheduled to undergo any lung cancer surgery (Cohort 4)

    • Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)

    • Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):

    • High risk/very high localized, locally advanced,

    • Biochemically recurrent prostate cancer

    • Treatment naïve, low-volume metastatic prostate cancer

    • Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort

    • Individuals without cancer <50 years of age (Cohort 8)

    • Individuals without cancer ≥50 years of age (Cohort 9)

    • 18 to 90 years old at the time of consent

    • Willing and able to download the Withings Health Mate app onto their personal mobile device

    • Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent

    • Willing to provide informed consent

    Exclusion Criteria:

    Project 1: HealthKit

    • Unable or unwilling to successfully export and share physiological data

    Project 2: DigIT-Ex

    • Unable or unwilling to appropriately use digital platforms or devices

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Lee Jones, PhD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05390827
    Other Study ID Numbers:
    • 20-330
    First Posted:
    May 25, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Remote Digital Physiological Data Collection
    Exercise Oncology
    20-330

    Study Results

    No Results Posted as of Aug 19, 2022