N/A
Completed N=25
Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies
Source: ClinicalTrials.gov NCT02410252 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Percent of Participants That Successfully Used the iThermonitor — 100; 75; 63 % of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants That Successfully Used the iThermonitor |
100; 75; 63 | — |
| SECONDARY Care Giver Anxiety |
12; 3; 1; 3; 16; 2 | 0.13 |
| SECONDARY Usability, Acceptability and Satisfaction |
8; 9; 0; 2; 13; 6 | 0.05 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02410252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.