Hypothalamic dysfunction Hypothalamic dysfunction after pediatric cancer
Conditions
Interventions
Wearing the Corsano CardioWatch 287-2
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age (at time of study enrolment) between 6-40 years; - Diagnosed with hypothalamic dysfunction by an endocrinologist. Hypothalamic dysfunction is diagnosed as having at least two of the following symptoms: *having a decreased resting energy expenditure
Exclusion criteria
Exclusion criteria: - Age (at time of study enrolment) <6 or >40 years - Patients actively undergoing intensive treatment for (supra)sellar tumor - Illiteracy in patient or caregiver - Language barrier, despite involvement of interpreter and translation of study information. - Pre-existing skin conditions to the upper extremities, such as psoriasis, (severe) eczema. - Informed consent has not been received
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter of this study is the score on a 5-point Likert scale as answer to the question posed in the PREM questionnaire at T2: "The use of the EndoWatch has supported me in the management of the consequences of hypothalamic dysfunction" (for participant), OR "The use of the EndoWatch has supported me in the management of the consequences of hypothalamic dysfunction of my child" (for parent) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters of this study are: 1. Management of hypothalamic dysfunction assessed per domain: A. Management of temperature dysregulation: - Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to the questions in the section 'Managing Body Temperature'. - Difference in average delta of wrist temperature per day (* = maximum_temp - minimum_temp) measured by the EndoWatch, between the first and last 4 weeks of the study. B. Management of sleep problems: - Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to the questions in the section 'Managing Sleep'. - Intraindividual changes of total scores measured by PROMIS Sleep Disturbances Short Form (Appendix C) between T0 - T1 - T2. - Intraindividual changes of scores measured by PROMIS Sleep Related Impairment Short Form (Appendix D) between T0 - T1 - T2. C. Management of daily activity: - Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to the questions in the section 'Managing daily activity'. - Difference between average number of steps per day measured by EndoWatch of the first 4 weeks compared to average number of steps per day measured by EndoWatch of the last 4 weeks of the study. D. Management of hypocortisolism during episodes of increased physical or emotional stress: - Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to the questions in the section 'Managing stress or illness'. E. Management of AVP deficiency: - Score on a 5-point Likert scale in the PREM questionnaire, answered at T2, to the questions in the section 'Managing desmopressin use'. 2. Explorative comparison of EndoWatch measurements to current home measurements of patients with hypothalamic dysfunction, assessed per domain: A. Comparison of EndoWatch measurement of wrist temperature with current home measurement of temperature: - Difference between EndoWatch measurements of wrist temperature to self-measured ear or rectal thermo | — |
Countries
Netherlands
Contacts
Public ContactH.M. van Santen
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed