Collecting health data remotely from cancer patients
Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol
This study is trying to see if collecting health information from cancer patients using mobile technology can help us understand how their condition and treatments affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3644 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05390827 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a secure method for collecting physiological data from cancer patients to better understand the relationship between this data and cancer diagnosis and treatment responses. It will recruit 3,000 patients with various stages of solid tumors and 500 adults without a cancer history as a comparison group. The study will utilize mobile technology to gather data and will focus on different patient cohorts, including those pre-treatment, post-treatment, and those with advanced disease. The goal is to identify factors that may influence cancer risk and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with newly diagnosed solid tumors, those post-treatment, or adults without a cancer history.
Not a fit: Patients with non-solid tumors or those who do not own an Apple iPhone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance personalized cancer care by providing insights into how physiological data relates to treatment responses.
How similar studies have performed: Other studies utilizing remote data collection in oncology have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Project 1: HealthKit * Individuals who meet at least one of the following criteria: * Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor * Historical diagnosis of primary invasive solid tumor * Diagnosis of metastatic (stage IV) or high-grade (III-IV) disease * Enrolled onto an investigational trial in the EDD Service * Seen in the MSK UCC from 2021 and onwards * Completion of Survivorship Patient Self-Assessment * Adult without a history of cancer \<50 years of age * Adult without a history of cancer ≥ 50 years of age * ≥18 years old * Own an Apple iPhone with valid iOS operating software * Have a registered MSK MyChart account and be willing to download the MSK Remote Monitoring (RM) application onto their personal iPhone * Self-reported "very well" comprehension of written and verbal English language * Willing and able to provide informed consent and HIPAA authorization for the release of personal health information 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 2) * 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 7) * 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 /or share physiological data Project 2: DigIT-Ex * Unable or unwilling to appropriately use digital platforms or devices
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Luke Pike, MD, DPhil — Memorial Sloan Kettering Cancer Center
- Study coordinator: Luke Pike, MD, DPhil
- Email: jonesl3@mskcc.org
- Phone: 212-639-8157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.