Clinical trial · Interventional
Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
- 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)
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.
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 |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention - Ewing Battery Assessment | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Device | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Screening (COMPASS31 + battery assessment + heart monitor)
- description
- 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.
- interventionNames
- Other: Exercise Intervention - Ewing Battery Assessment
- Other: Questionnaire Administration
- Device: Medical Device Usage and Evaluation
- type
- EXPERIMENTAL
- label
- Screening (battery assessment + COMPASS31 + heart monitor)
- description
- 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.
- interventionNames
- Other: Exercise Intervention - Ewing Battery Assessment
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available