Clinical trial · Observational
Cardiac Autonomic Dysfunction in Childhood Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This protocol was placed on hold in January 2023 as funding was not received to support study activities and recruitment was never initiated. This protocol will be fully closed as new projects are underway that support similar outcome measures.
Summary
Brief summary (as posted)
This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study. Primary Objective Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions. Secondary Objectives Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autonomic Dysfunction | — | UNRESOLVED | — |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participants
- description
- Those who meet the Eligibility Criteria will be asked to complete online questionnaires and wear a device on your wrist for two weeks that measures your heart rate, physical activity, and sleep. A WHOOP® wrist monitor and charging equipment will be used.
Primary outcomes (1)
- measure
- Heart rate variability
- timeFrame
- Measured over a 24 hour period
- description
- Standard deviation of NN (normal to normal RR) intervals (SDNN)
Secondary outcomes (11)
- measure
- Autonomic Symptoms
- timeFrame
- Assessed at baseline
- description
- Self-reported autonomic symptoms via the COMPASS31
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Enrollment on the CCSS protocol. * 18 years or older. * Has a smartphone and is willing to download the WHOOP® app for the duration of study participation. * Reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables. Exclusion Criteria: * Unable to independently provide informed consent. * Visual impairment that prevents participant from engaging with study materials. * Unable to read or understand study materials in English. * Mailing address outside the United States.
References
Publications (0)
Data not yet available