Hodgkin DiseaseNCT03838627
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)
An observational study of Hodgkin Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: St. Jude Patients
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hodgkin Disease
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minute electrocardiogram recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start5 Feb 2019
- Primary completion19 Jan 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten K Ness, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838627
- Sponsor's protocol ID
- WHOOPHPP
- Other IDs
- NCI-2021-05183
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2019
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03838627
- Acronym / sponsor ID
- WHOOPHPP
- Conditions
- Hodgkin Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- St. Jude Patients
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 48 hours
Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.
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.
Time frame: 10 minute electrocardiogram recording
A mean discrepancy of <20 msec for SDNN measured by the two methods will be considered acceptable agreement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- St. Jude Childen's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St.JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten K Ness, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.