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)

NCT03838627 | Completed DMC

• 2 other identifiers: WHOOPHPPNCI-2021-05183
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.

  48 hours

• 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.

  A mean discrepancy of \<20 msec for SDNN measured by the two methods will be considered acceptable agreement.

  10 minute electrocardiogram recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

St. Jude Patients

You may qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

Kirsten Ness

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Childen's Research Hospital
• Clinical Trials Open at St.Jude

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kirsten K Ness, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 12, 2019
• Study Start: February 5, 2019
• Primary Completion: January 19, 2021
• Study Completion: June 30, 2023
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)