Autonomic DysfunctionNCT05132673
Cardiac Autonomic Dysfunction in Childhood Cancer Survivors
An observational study of Autonomic Dysfunction and Childhood Cancer, run by St. Jude Children's Research Hospital.
Trial summary
This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study. Primary Objective Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Dysfunction, Childhood Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jul 2026
- 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: Those who meet the eligibility criteria
Who may be able to join
- Enrollment on the CCSS protocol.
- 18 years or older.
- Has a smartphone and is willing to download the WHOOP® app for the duration of study participation.
- Reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables.
Who cannot join
- Unable to independently provide informed consent.
- Visual impairment that prevents participant from engaging with study materials.
- Unable to read or understand study materials in English.
- Mailing address outside the United States.
About this study
This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study.
Primary Objective
Read more
Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions.
Secondary Objectives
Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.
Read the detailed description
Potential participants will be recruited by email and phone. Survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. This data collection will take place in DatStat Connect, which is the online consenting and data collection tool utilized for the CCSS. Consented/enrolled SJLIFE participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a WHOOP® strap prior kit prior to scheduling a device setup session with a team member. The kit will include the WHOOP® strap, brief instructions for setup, and prepaid return mailing materials. The WHOOP® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)
- Conditions
- Autonomic Dysfunction, Childhood Cancer
- Keywords
- childhood cancer survivors, cardiac
- Medical subject headings
- Primary Dysautonomias, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Those who meet the Eligibility Criteria will be asked to complete online questionnaires and wear a device on your wrist for two weeks that measures your heart rate, physical activity, and sleep. A WHOOP® wrist monitor and charging equipment will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Standard deviation of NN (normal to normal RR) intervals (SDNN)
Measured: Measured over a 24 hour period
Secondary outcomes (11)
Autonomic Symptoms
Self-reported autonomic symptoms via the COMPASS31
Measured: Assessed at baseline
Perceived health
Self-reported perceived health via Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Measured: Assessed at baseline
Perceived stress
Cohen's Perceived Stress Scale, Minimum value = 0, Maximum value = 40, Higher scores mean a worse outcome
Measured: Assessed at baseline
Cognitive status
Childhood Cancer Survivor Study Neurocognitive Questionnaire, Minimum Value = 33, Maximum value = 99, Higher scores mean a worse outcome
Measured: Assessed at baseline
Sleep Onset
Sleep hygiene will be measured via wearable sleep tracker. Sleep onset will be measured in minutes.
Measured: Measured over 2 weeks
Wake Onset
Sleep hygiene will be measured via wearable sleep tracker. Wake onset will be measured in minutes.
Measured: Measured daily over 2 weeks
Sleep efficiency
Sleep hygiene will be measured via wearable sleep tracker. Sleep efficient will be measured by dividing the minutes asleep by the total minutes in bed.
Measured: Measured daily over 2 weeks
Physical activity duration
Intensity and duration of daily activity will be measured via wearable activity tracker. Activity duration will be measured in minutes.
Measured: Measured daily over 2 weeks
Workout strain
Intensity and duration of daily activity will be measured via wearable activity tracker. Workout strain will be calculated by the duration of time in personal heart rate zones, established from maximum heart rate.
Measured: Measured daily over 2 weeks
Maximum heart rate
Intensity and duration of daily activity will be measured via wearable activity tracker. Maximum heart rate will be calculated by subtracting age from 220 and is measured in beats per minute.
Measured: Measured daily over 2 weeks
Average heart rate
Intensity and duration of daily activity will be measured via wearable activity tracker. Average heart rate will be calculated as number of beats per minute.
Measured: Measured daily over 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: This protocol was placed on hold in January 2023 as funding was not received to support study activities and recruitment was never initiated. This protocol will be fully closed as new projects are underway that support similar outcome measures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten W. Ness, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132673
- Sponsor's protocol ID
- WEARIT
- Other IDs
- NCI-2022-00145
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Dysfunction in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT05132673
- Acronym / sponsor ID
- WEARIT
- Conditions
- Autonomic Dysfunction, Childhood Cancer
- Keywords
- childhood cancer survivors, cardiac
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This protocol was placed on hold in January 2023 as funding was not received to support study activities and recruitment was never initiated. This protocol will be fully closed as new projects are underway that support similar outcome measures.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Nov 2021 (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.
This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study.
Primary Objective
Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions.
Secondary Objectives
Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.
Detailed description
Potential participants will be recruited by email and phone. Survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. This data collection will take place in DatStat Connect, which is the online consenting and data collection tool utilized for the CCSS. Consented/enrolled SJLIFE participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a WHOOP® strap prior kit prior to scheduling a device setup session with a team member. The kit will include the WHOOP® strap, brief instructions for setup, and prepaid return mailing materials. The WHOOP® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Those who meet the Eligibility Criteria will be asked to complete online questionnaires and wear a device on your wrist for two weeks that measures your heart rate, physical activity, and sleep. A WHOOP® wrist monitor and charging equipment will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who meet the eligibility criteria
Key inclusion criteria (4 listed)
- Enrollment on the CCSS protocol.
- 18 years or older.
- Has a smartphone and is willing to download the WHOOP® app for the duration of study participation.
- Reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables.
Key exclusion criteria (4 listed)
- Unable to independently provide informed consent.
- Visual impairment that prevents participant from engaging with study materials.
- Unable to read or understand study materials in English.
- Mailing address outside the United States.
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
Heart rate variability
Time frame: Measured over a 24 hour period
Standard deviation of NN (normal to normal RR) intervals (SDNN)
11 secondary outcomes
Autonomic Symptoms
Time frame: Assessed at baseline
Perceived health
Time frame: Assessed at baseline
Perceived stress
Time frame: Assessed at baseline
Cognitive status
Time frame: Assessed at baseline
Sleep Onset
Time frame: Measured over 2 weeks
Wake Onset
Time frame: Measured daily over 2 weeks
Sleep efficiency
Time frame: Measured daily over 2 weeks
Physical activity duration
Time frame: Measured daily over 2 weeks
Workout strain
Time frame: Measured daily over 2 weeks
Maximum heart rate
Time frame: Measured daily over 2 weeks
Average heart rate
Time frame: Measured daily over 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Autonomic Dysfunction
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
Active, not recruitingPhase 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
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 W. Ness, PhD principal investigator
St. Jude Children's Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysfunction and Childhood Cancer, run by St. Jude Children's Research Hospital.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Heart rate variability (time frame: Measured over a 24 hour period). 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 24 Apr 2026.