Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

• ClinicalTrials.gov Identifier: NCT03330080
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Last Update Posted: March 8, 2019
• Sponsor: St. Jude Children's Research Hospital
• Collaborator: Virginia Commonwealth University
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment
• Actual Study Start Date: February 12, 2018
• Actual Primary Completion Date: January 29, 2019
• Actual Study Completion Date: January 29, 2019

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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)

Contacts and Locations

Locations

United States, Tennessee

St . Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Virginia Commonwealth University

Investigators

• Principal Investigator: Valerie Crabtree, PhD; St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital 

clinical Trials Open at St. Jude 

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT03330080
• Other Study ID Numbers: SAFF
• First Posted: November 6, 2017
• Last Update Posted: March 8, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:

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

Additional relevant MeSH terms:

Craniopharyngioma; Adamantinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Bone Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases