Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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
- description
- Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.
- 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
- description
- A mean discrepancy of \<20 msec for SDNN measured by the two methods will be considered acceptable agreement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available