Clinical trial NCT03838627: Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)
Official title: Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: St. Jude Patients

Brief summary: Primary Objective The objective is to determine the feasibility and agreement of remote evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St. Jude Life Study participants with a history of mantle radiation for management of Hodgkin lymphoma.

Elucidating the mechanisms that contribute to adverse cardiovascular outcomes and reduced quality of life among the growing population of childhood cancer survivors is paramount. Cancer, certain cancer drugs, radiation therapy, cancer-associated lifestyle disturbances, and cancer-independent comorbidities combine to predispose cancer survivors to autonomic dysfunction (AD). Reduced heart rate variability (HRV) has been described in various cancer cohorts. Furthermore, these markers of AD have been implicated in adverse outcomes in oncology patients, including increased mortality, exercise limitation, and fatigue. However, data are largely derived from small studies with methodological limitations, and the contribution of AD to overall morbidity and mortality in cancer survivors is not well understood.

The objective is to determine the feasibility and agreement of remote evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St. Jude Life Study participants with a history of mantle radiation for management of Hodgkin lymphoma.

Detailed description: At St. Jude Children's Research Hospital survivors who meet the eligibility criteria will be identified from SJLIFE participants and contacted for potential participation via phone. If the SJLIFE participant expresses interest they will be e-mailed or faxed a copy of the consent form; the consent conference will occur via phone and e-mail or facsimile will be used to document informed consent. Once the consent signature page is received and the participant is enrolled on study, a WHOOP® wrist monitor and directions for wearing the device will be mailed to the participant. Feasibility will be assessed by evaluating how many participants wear and return the device with enough data for analysis. The investigator will consider the project feasible if 30 of 40 participants have 3 hours of usable data after removal of noise. Upon arrival at St. Jude for the St Jude LIFE study, the participant will undergo in-office measurement of HRV while also wearing the WHOOP® device. A standard 10-minute electrocardiogram recording will be performed with the participant in a supine position, with a regular and calm breathing pattern in a quiet room. The standard deviation of normal RR intervals (SDNN, msec) will be derived from SphygmoCor HRV Software. SDNN during this 10-minute time period will be derived from WHOOP® HRV software. Agreement between measures of SDNN derived by the two techniques will be assessed. A mean discrepancy of \<20 msec for SDNN measured by the two methods will be considered acceptable agreement.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the SJLIFE study.
* Survivor of childhood Hodgkin lymphoma.
* Exposure to ≥ 20 Gy chest radiation
* Is 18 years of age and older.
* No evidence of cancer recurrence.
* Non-smoker at time of study participation.
* Willingness to avoid caffeine for 3-4 hours and alcohol for 8 hours prior to testing.
* No history of allergic reactions to ECG electrodes.
* Has a smart phone and is willing to download the WHOOP app to their smartphone

Exclusion Criteria:

NA

Primary outcomes:
measure: The number of patients who wear, return and have sufficient data for analysis of resting heart rate and HRV after removal of noise by WHOOP® HRV software data analysis algorithms.
timeFrame: 48 hours
measure: The degree of agreement between measurements of continuous HRV parameters derived from the two methods will be assessed using linear regression, Pearson's correlation coefficient and Bland Altman analysis.
timeFrame: 10 minute electrocardiogram recording
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Kirsten Ness
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten K Ness, PhD
role: PRINCIPAL_INVESTIGATOR
References: