Clinical trial NCT03330080: Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients
Official title: Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniopharyngioma
Keywords: Ecological momentary assessment
Sleepiness
Fatigue
Endocrinopathy
Family functioning
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2017-11-06
Enrollment: 41
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for the proposed study will be children who participated in the parent study (ages 8-18 at the time of enrollment on RT2CR) and have an ongoing relationship with the study team. They will be contacted during their follow-up clinic visits and invited to participate in this additional study. Parental consent and participant assent (if age \<18) or consent (if age ≥18) for the proposed study will be obtained in-person.

Two institutions will collaborate in the proposed project: St. Jude Children's Research Hospital (SJCRH) and Virginia Commonwealth University (VCU), however, recruitment, patient enrollment, and data collection will only take place at St. Jude.

Brief summary: Pediatric craniopharyngioma patients experience significant endocrine and sleep dysregulation difficulties. Sleep is a crucial part of children's healthy development, and sleep difficulties are associated with severe functional morbidity. Insufficient sleep, excessive daytime sleepiness, and poor sleep quality have all been significantly related to academic, behavioral, and emotional functioning in children and adolescents. Ecological momentary assessments (EMA) will be used to collect observational data.

EMA data will be collected twice daily for one week. For the morning EMA administration, participants will be asked about their sleep. During the evening administration, participants will be asked about their daytime sleepiness, overall well-being, and family functioning. Covariates also administered during the evening administration include medication administration (Y/N) and total screen time. At the end of the EMA data collection period (on day 7 OR 8), participants will be sent a survey asking them to report - anonymously - their overall experience and satisfaction with the EMA data collection method.

Detailed description: After recruitment and informed consent/assent is obtained for the current study, participants will be asked to complete a questionnaire battery online (via REDCap) assessing sleep habits, daytime sleepiness, family routines, family functioning, and overall quality of life in the past six months. The relationship between subjective sleep ratings obtained from the parent craniopharyngioma study at St. Jude (RT2CR) at diagnosis and 3 months later (T1 and T2) and family functioning/routines at the follow-up study (T3) will be assessed. The researchers have permission to use data for all participants who consent to participate in this follow-up EMA study.

Children will be sent electronic surveys two times per day (i.e., morning and evening) for seven days using Ilumivu software (https://ilumivu.com/mema-demo). Ilumivu is an established EMA tool that offers an in-mobile app for participants to respond to questionnaires in real time with limited burden. This application will send notifications to participants to remind them to complete surveys and record response times for each survey.

Eligibility criteria: Inclusion Criteria:

* Craniopharyngioma diagnosis
* Access to smartphone or a tablet
* Agreement to download Ilumivu application
* The ability for the participant to answer questionnaires (i.e., no cognitive or developmental diagnoses that would preclude understanding and completing child self-report questionnaires)
* Age between 8 and 18 years old at the time of enrollment onto St. Jude protocol RT2CR.
* Participated in sleep study component of RT2CR

Exclusion Criteria:

* Limited English proficiency as evidenced by an inability to read and respond to EMA survey questions
* Visual or sensorimotor impairment (e.g., loss of sight)

Primary outcomes:
measure: Rate of participation
timeFrame: Once at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St . Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Valerie Crabtree, PhD
role: PRINCIPAL_INVESTIGATOR
References: