Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Craniopharyngioma

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St . Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ecological momentary assessment (EMA); The ecological momentary assessment (EMA) will be used for participants to complete surveys from home on two occasions each day over seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participation	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.	Once at enrollment

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: Virginia Commonwealth University

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): January 29, 2019
• Study Completion (Actual): January 29, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Fatigue; Sleepiness; Family functioning; Ecological momentary assessment; Endocrinopathy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Bone Diseases; Bone Neoplasms; Craniopharyngioma; Adamantinoma
• Other Study ID Numbers: SAFF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No