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Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a wearable sensor used remotely can find problems with the nerves that control the heart as accurately as in-person tests. It also tests a survey about symptoms. The study is for adults in the St. Jude Lifetime Cohort who survived certain types of leukemia or lymphoma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be enrolled in the St. Jude Lifetime Cohort (SJLIFE) and be older than 18.
  • Have had acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma as your main cancer diagnosis.
  • Not currently take beta-blockers, medicines that slow the heart rate.

Who can't join

  • Cannot speak, read, or understand English.
  • Cannot follow directions to finish the Ewing battery, a set of tests of the nerves that control the heart.
  • Have acute heart failure, meaning new or worsening heart failure symptoms, such as trouble breathing or swollen legs.
  • Are currently pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TN