CraniopharyngiomaNCT03330080
Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients
An observational study of Craniopharyngioma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Craniopharyngioma
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 29 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: 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.
Read the 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.
- Conditions
- Craniopharyngioma
- Keywords
- Ecological momentary assessment, Sleepiness, Fatigue, Endocrinopathy, Family functioning
- Medical subject headings
- Craniopharyngioma, Sleepiness, Fatigue, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start12 Feb 2018
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Valerie Crabtree, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330080
- Sponsor's protocol ID
- SAFF
- Status last verified
- Mar 2019
- First submitted
- 31 Oct 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT03330080
- Acronym / sponsor ID
- SAFF
- Conditions
- Craniopharyngioma
- Keywords
- Ecological momentary assessment, Sleepiness, Fatigue, Endocrinopathy, Family functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Crabtree, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniopharyngioma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participation (time frame: Once at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.