Clinical trial NCT06747910: Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
Official title: Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Keywords: Survivor
Acute lymphoblastic leukemia
Hodgkins's lymphoma
Autonomic
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart rate variability (msec)
timeFrame: Up to 7 days after the on-campus study visit
measure: Abbreviated Composite Autonomic Symptom Score (0-100)
timeFrame: During the on-campus study visit (Day 1)
measure: Ewing Score (0-5)
timeFrame: During the on-campus study visit (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Carmen Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: