Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

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.

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Key information

Conditions

Craniopharyngioma Endocrine System Diseases Fatigue Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleepiness

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Rate of participation

Time frame: Once at enrollment

Study feasibility will be assessed by calculating the participation rate as follows: the number of participants who agree to participants divided by the number who are approached to participate.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

Virginia Commonwealth University

Registry information

Official study title

Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Nov 6, 2017
Registry last updated: Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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