Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol
Recruiting
Observational Study
Solid Tumor
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
3,692 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility 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)…
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 or Android with valid operating software
* 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)
* Receiving outpatient care at Memorial Sloan Kettering Cancer Center (MSK)(Cohort 10)
* Diagnosed with metastatic cancer to bone (Cohort 10)
* Scheduled for non-emergent orthopaedic surgery to stabilize lower-extremity bone metastases (Cohort 10)
* Able to undergo at least 5 consecutive days of preoperative monitoring prior to surgery (Cohort 10)
* Have had a CT scan including the L3 vertebral level within 3 months before surgery (used to assess skeletal muscle mass and sarcopenia) (Cohort 10)
* Have a ≥50% predicted likelihood of 6-month postoperative survival, as estimated by the PATHFx clinical decision-support tool (Cohort 10
* 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 for Cohorts 1-9, and 4 months following consent for Cohort 10.
* 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
* Require a wheelchair for ambulation (Cohort 10)
* Are undergoing stabilization surgery for a primary bone tumor (rather than metastatic disease) (Cohort 10)
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