Childhood CancerNCT06747910
Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
A study testing Exercise Intervention - Ewing Battery Assessment, Questionnaire Administration and Medical Device Usage and Evaluation in people with Childhood Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This study seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Exercise Intervention - Ewing Battery Assessment, Questionnaire Administration and Medical Device Usage and Evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) >18 years of age.
- Primary diagnosis of acute lymphoblastic leukemia (ALL), Hodgkin's Lymphoma (HL), or Non-Hodgkin's Lymphoma (Non-HL).
- Not currently taking beta-blocker medication.
Who cannot join
- Individuals who cannot speak, read, and/or understand English.
- Individuals who are unable to follow directions/instructions in order to complete the Ewing battery.
- Individuals with acute heart failure (new or worsening signs and symptoms of heart failure, including a combination of the following: dyspnea, orthopnea, lower limb swelling, elevated jugular venous pressure, and pulmonary congestion).
- Women who are currently pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Kirsten K Ness, PhD, 888-226-4343, referralinfo@stjude.org
Kirsten K Ness, PhD
About this study
This study seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Childhood cancer survivors, particularly survivors of acute lymphoblastic leukemia (ALL) and Hodgkins's lymphoma (HL), appear to be at increased risk for AD.
Primary Objectives:
- To determine the sensitivity and specificity of heart rate variability (HRV), measured remotely with biosensor technology (Actigraph LEAP), compared to in-person assessment using the Ewing battery as the reference standard to identify cardiac autonomic dysfunction (AD) among survivors of leukemia and lymphoma.
- To determine the sensitivity and specificity of the Composite Autonomic Symptom Scale 31 (COMPASS31) compared to the Ewing battery to identify AD among leukemia and lymphoma survivors.
Read the detailed description
Each participant will complete an in-person standardized clinical assessment for AD, called the Ewing battery. during the participants' Human Performance Lab during their SJLIFE functional exam. It is estimated it will take 60-90-minutes to complete the Ewing battery. The tests include monitoring heart rate variations during deep breathing and lying down to standing, as well as monitoring blood pressure variations when standing and maintaining hand grip. Participants will be asked to not consume aspirin, ibuprofen or acetaminophen 24-hours before the assessment. Additionally, participants will be asked to avoid alcohol or caffeine within 6-hours, and smoking 3-hours, before testing.
After the in-person assessment, each participant will be given a wrist biosensor to remotely monitor heart rate variability for 7 days after they return home. Participants will also complete an AD symptom questionnaire, COMPASS31. The AD symptom questionnaire will be completed either before or after the in-person assessment. This questionnaire will take about 20-30 minutes to complete.
- Conditions
- Childhood Cancer
- Being tested
- Exercise Intervention - Ewing Battery Assessment, Questionnaire Administration, Medical Device Usage and Evaluation
- Keywords
- Survivor, Acute lymphoblastic leukemia, Hodgkins's lymphoma, Autonomic
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention - Ewing Battery AssessmentOther
Undergo in-person Ewing battery assessment
Questionnaire AdministrationOther
Receive COMPASS31 questionnaire
Medical Device Usage and EvaluationDevice
Wear biosensensor heart monitor that remotely collects heart rate variability.
| Study group | Role | What they receive |
|---|---|---|
| Screening (COMPASS31 + battery assessment + heart monitor) | Experimental | Patients complete the COMPASS31 questionnaire and undergo an in-person Ewing battery assessment over 60-90 minutes on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study. Receives: Other: Exercise Intervention - Ewing Battery Assessment; Other: Questionnaire Administration; Device: Medical Device Usage and Evaluation |
| Screening (battery assessment + COMPASS31 + heart monitor) | Experimental | Patients undergo an in-person Ewing battery assessment over 60-90 minutes and complete the COMPASS31 questionnaire on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study. Receives: Other: Exercise Intervention - Ewing Battery Assessment; Other: Questionnaire Administration; Device: Medical Device Usage and Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (msec)
The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds
Measured: Up to 7 days after the on-campus study visit
Abbreviated Composite Autonomic Symptom Score (0-100)
Symptom burden-based questionnaire of six weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal bladder and pupillomotor)
Abbreviated Composite Autonomic Symptom Score:
- This questionnaire, administered during Day 1, generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. Scores are determined by applying a simplified scoring algorithm.
- Overall score interpretation:
- < 3 or less: Mild
- 3-7: Moderate
- >7: Severe
Measured: During the on-campus study visit (Day 1)
Ewing Score (0-5)
Derived from sum of five individual autonomic test scores
Ewing Battery Scoring:
- This battery is administered during Day 1. Each test within the battery (5 tests total) is assigned a score of 0 (normal), 0.5 (borderline), or 1 (abnormal).
- Overall score interpretation:
- 0-1: Considered normal autonomic function
- 1.5-2: Mild autonomic dysfunction
- 2.5-3: Moderate autonomic dysfunction
- 3.5-5: Severe autonomic dysfunction
Measured: During the on-campus study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will complete an in-person assessment questionnaire for autonomic dysfunction (AD), during a scheduled on-campus SJLIFE visit and a remote assessment. Participants will be randomly assigned to either complete the AD symptom questionnaire before or after the standardized clinical AD assessment. Participants will be asked to wear a heart rate variability monitor for 7 days after the on-campus visit
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
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
- NCT06747910
- Sponsor's protocol ID
- READ
- Other IDs
- NCI-2025-00603
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT06747910
- Acronym / sponsor ID
- READ
- Conditions
- Childhood Cancer
- Keywords
- Survivor, Acute lymphoblastic leukemia, Hodgkins's lymphoma, Autonomic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Dec 2024 (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 seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Childhood cancer survivors, particularly survivors of acute lymphoblastic leukemia (ALL) and Hodgkins's lymphoma (HL), appear to be at increased risk for AD.
Primary Objectives:
- To determine the sensitivity and specificity of heart rate variability (HRV), measured remotely with biosensor technology (Actigraph LEAP), compared to in-person assessment using the Ewing battery as the reference standard to identify cardiac autonomic dysfunction (AD) among survivors of leukemia and lymphoma.
- To determine the sensitivity and specificity of the Composite Autonomic Symptom Scale 31 (COMPASS31) compared to the Ewing battery to identify AD among leukemia and lymphoma survivors.
Detailed description
Each participant will complete an in-person standardized clinical assessment for AD, called the Ewing battery. during the participants' Human Performance Lab during their SJLIFE functional exam. It is estimated it will take 60-90-minutes to complete the Ewing battery. The tests include monitoring heart rate variations during deep breathing and lying down to standing, as well as monitoring blood pressure variations when standing and maintaining hand grip. Participants will be asked to not consume aspirin, ibuprofen or acetaminophen 24-hours before the assessment. Additionally, participants will be asked to avoid alcohol or caffeine within 6-hours, and smoking 3-hours, before testing.
After the in-person assessment, each participant will be given a wrist biosensor to remotely monitor heart rate variability for 7 days after they return home. Participants will also complete an AD symptom questionnaire, COMPASS31. The AD symptom questionnaire will be completed either before or after the in-person assessment. This questionnaire will take about 20-30 minutes to complete.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete an in-person assessment questionnaire for autonomic dysfunction (AD), during a scheduled on-campus SJLIFE visit and a remote assessment. Participants will be randomly assigned to either complete the AD symptom questionnaire before or after the standardized clinical AD assessment. Participants will be asked to wear a heart rate variability monitor for 7 days after the on-campus visit
| Arm | Type | Receives |
|---|---|---|
| Screening (COMPASS31 + battery assessment + heart monitor) | Experimental | Other: Exercise Intervention - Ewing Battery Assessment, Other: Questionnaire Administration, Device: Medical Device Usage and EvaluationPatients complete the COMPASS31 questionnaire and undergo an in-person Ewing battery assessment over 60-90 minutes on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study. |
| Screening (battery assessment + COMPASS31 + heart monitor) | Experimental | Other: Exercise Intervention - Ewing Battery Assessment, Other: Questionnaire Administration, Device: Medical Device Usage and EvaluationPatients undergo an in-person Ewing battery assessment over 60-90 minutes and complete the COMPASS31 questionnaire on study. Patients then wear a biosensensor heart monitor for 7 days to monitor heart rate variability remotely on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) >18 years of age.
- Primary diagnosis of acute lymphoblastic leukemia (ALL), Hodgkin's Lymphoma (HL), or Non-Hodgkin's Lymphoma (Non-HL).
- Not currently taking beta-blocker medication.
Key exclusion criteria (4 listed)
- Individuals who cannot speak, read, and/or understand English.
- Individuals who are unable to follow directions/instructions in order to complete the Ewing battery.
- Individuals with acute heart failure (new or worsening signs and symptoms of heart failure, including a combination of the following: dyspnea, orthopnea, lower limb swelling, elevated jugular venous pressure, and pulmonary congestion).
- Women who are currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Intervention - Ewing Battery AssessmentUndergo in-person Ewing battery assessment | Other | Screening (COMPASS31 + battery assessment + heart monitor), Screening (battery assessment + COMPASS31 + heart monitor) |
| Questionnaire AdministrationReceive COMPASS31 questionnaire | Other | Screening (COMPASS31 + battery assessment + heart monitor), Screening (battery assessment + COMPASS31 + heart monitor) |
| Medical Device Usage and EvaluationWear biosensensor heart monitor that remotely collects heart rate variability. | Device | Screening (COMPASS31 + battery assessment + heart monitor), Screening (battery assessment + COMPASS31 + heart monitor) |
Primary outcome
Heart rate variability (msec)
Time frame: Up to 7 days after the on-campus study visit
The standard deviation of normal-to-normal heartbeat intervals over a 24-hour period measured in milliseconds
Abbreviated Composite Autonomic Symptom Score (0-100)
Time frame: During the on-campus study visit (Day 1)
Symptom burden-based questionnaire of six weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal bladder and pupillomotor) Abbreviated Composite Autonomic Symptom Score: * This questionnaire, administered during Day 1, generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. Scores are determined by applying a simplified scoring algorithm. * Overall score interpretation: * < 3 or less: Mild * 3-7: Moderate * >7: Severe
Ewing Score (0-5)
Time frame: During the on-campus study visit (Day 1)
Derived from sum of five individual autonomic test scores Ewing Battery Scoring: * This battery is administered during Day 1. Each test within the battery (5 tests total) is assigned a score of 0 (normal), 0.5 (borderline), or 1 (abnormal). * Overall score interpretation: * 0-1: Considered normal autonomic function * 1.5-2: Mild autonomic dysfunction * 2.5-3: Moderate autonomic dysfunction * 3.5-5: Severe autonomic dysfunction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 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: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
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?
A study testing Exercise Intervention - Ewing Battery Assessment, Questionnaire Administration and Medical Device Usage and Evaluation in people with Childhood Cancer, 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 3 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten K Ness, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (msec) (time frame: Up to 7 days after the on-campus study visit). The study lists 3 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 16 Jul 2026.