Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

NCT03330080 | Completed

• 1 other identifier: SAFF
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniopharyngioma

Keywords

Ecological momentary assessment; Sleepiness; Fatigue; Endocrinopathy; Family functioning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Craniopharyngioma; Sleepiness; Fatigue; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerie Crabtree, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: February 12, 2018
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)