St. Jude Children's Research Hospital
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.
Childhood Cancer
Exercise Intervention - Ewing Battery Assessment
Questionnaire Administration
Medical Device Usage and Evaluation
NA
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 188 participants |
| Masking : | NONE |
| Primary Purpose : | SCREENING |
| Official Title : | Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma |
| Actual Study Start Date : | 2025-02-03 |
| Estimated Primary Completion Date : | 2025-12 |
| Estimated Study Completion Date : | 2026-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105