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A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.
Modern-day wearable devices, such as Apple Watches or Fitbits, are widely available, non-invasive, and can provide continuous vital sign monitoring for the early detection of potential health complications. Early detection of things such as fever or increased heart rate can alert patients to seek medical attention sooner and therefore have the potential to improve patient outcomes and decrease healthcare costs.
To further investigate the feasibility of using remote patient monitoring ( RPM)to prospectively monitor patients undergoing outpatient chemotherapy for chemotherapy related toxicities, defined as follows: (1) patients answer queries through the Locus Health iPhone app at least 70% of the time; (2) patients report that the Locus Health iPhone app and the Apple Watch were 'easy to use,' defined as an average score of 7 or higher on the first two questions of the post-intervention questionnaire, and (3) fewer than 10% of patients withdraw from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Cohorts | Cohort 1: Daily from day 2 through the end of treatment cycle (n=34) Cohort 2: Daily days 2-9 then every third day through end of cycle (n=33) Cohort 3: Daily days 2-9 for all symptoms, every third day thereafter regarding 'pain' only through end of cycle (n=33) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locus Health iPhone App | Device | In this pilot study patients are enrolled into three (3) different groups which will vary by the frequency of the queries being sent to the patients during their chemotherapy cycle. The patients will be separated into three groups of 33-34 patients each. Each group will have a different frequency of symptom questions sent to them via the Locus Health iPhone App to determine patient fatigue and the compliance impact of different query cadences. Patients will be assigned to these 3 groups sequentially since the platform could not assign patients to these three cohorts in a random manner. |
| Measure | Description | Time Frame |
|---|---|---|
| The Use of Locus Heath iPhone App and the Apple Watch by Participants Undergoing Outpatient Chemotherapy. | The feasibility is determined when 80% of the patients wear the watch at least 70% of the time during waking hours. | 120 days or until the chemotherapy regimen has stopped, whichever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a wide range of solid tumor and malignant hematology malignancies will be enrolled
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elahe Mollapour | Contact | (571) 472-4724 | elahe.mollapour@inova.org | |
| Keary Jane't | Contact | Keary.Janet@inova.org |
| Name | Affiliation | Role |
|---|---|---|
| John Deeken, MD | Inova Schar Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Schar Cancer Institute | Recruiting | Fairfax | Virginia | 22031 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28856437 | Result | Heinz WJ, Buchheidt D, Christopeit M, von Lilienfeld-Toal M, Cornely OA, Einsele H, Karthaus M, Link H, Mahlberg R, Neumann S, Ostermann H, Penack O, Ruhnke M, Sandherr M, Schiel X, Vehreschild JJ, Weissinger F, Maschmeyer G. Diagnosis and empirical treatment of fever of unknown origin (FUO) in adult neutropenic patients: guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO). Ann Hematol. 2017 Nov;96(11):1775-1792. doi: 10.1007/s00277-017-3098-3. Epub 2017 Aug 30. | |
| 16575919 |
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If the patient is seen in the Emergency Room or hospitalized, the following data will be extracted:
The Apple/Locus Health RPM intervention will end and the patient will come off study when the chemotherapy regimen is stopped for any reason.
All patient records and end-of study questionnaires will be de-identified using a letter and number assigned to their case at the time of enrollment on study. No record used for the data analysis will contain information which could identify the patient. Only the delegated research team will have access to the 'key' which connects patient identifiable information with this assigned number For computer records, the key will be protected by a double-password protection system. Any paper records will be contained in a locked cabinet within a locked office to ensure patients' privacy is protected.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Result |
| Kuderer NM, Dale DC, Crawford J, Cosler LE, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006 May 15;106(10):2258-66. doi: 10.1002/cncr.21847. |
| 30629902 | Result | Zimmer AJ, Freifeld AG. Optimal Management of Neutropenic Fever in Patients With Cancer. J Oncol Pract. 2019 Jan;15(1):19-24. doi: 10.1200/JOP.18.00269. |
| 34765323 | Result | Verma N, Haji-Abolhassani I, Ganesh S, Vera-Aguilera J, Paludo J, Heitz R, Markovic SN, Kulig K, Ghoreyshi A. A Novel Wearable Device for Continuous Temperature Monitoring & Fever Detection. IEEE J Transl Eng Health Med. 2021 Jul 19;9:2700407. doi: 10.1109/JTEHM.2021.3098127. eCollection 2021. |