Clinical trial · Interventional
Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies
Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppresive Therapies for Acute Leukemia and Other Childhood Cancers
NCT02410252CI-TRIAL-00047801completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous temperature monitoring device, as a clinical support and patient self-management tool in the management of pediatrics patients on myelosuppressive therapies for acute leukemia and other childhood cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iThermonitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iThermonitor
- description
- Participants are asked to use the iThermonitor device for two weeks to monitor their temperature. Participants are asked to wear the device for as many hours as they can but at a minimum to wear while sleeping.
- interventionNames
- Device: iThermonitor
Primary outcomes (1)
- measure
- Percent of Participants That Successfully Used the iThermonitor
- timeFrame
- Two Weeks
- description
- This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. "Time in the study" here is defined as the number of days the subject spends in the study which is expected to be two weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Dyad consists of a pediatric patient aged 2-17 years undergoing myelosuppressive therapies for acute leukemias and other childhood cancers. * Dyad also includes a caregiver, ≥ 18 years of age that is willing to participate in the study. * Ability of caregiver or patient (if old enough) to read and speak English. * If applicable, willingness of the patient to shave axillary (armpit) hair. * Caregiver (parent or legal guardian) must give informed consent for dyad participation. Exclusion Criteria: * Patient has a history of allergy to hydrogel dressing or ongoing skin diseases * Patients with ongoing febrile illness or documented infectious disease.
References
Publications (1)
- DERIVEDKakarmath SS, de Redon E, Centi AJ, Palacholla R, Kvedar J, Jethwani K, Agboola S. Assessing the Usability of an Automated Continuous Temperature Monitoring Device (iThermonitor) in Pediatric Patients: Non-Randomized Pilot Study. JMIR Pediatr Parent. 2018 Dec 21;1(2):e10804. doi: 10.2196/10804. PMID 31518304