Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2015-03-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1: Pediatric patients
* Patients will wear a Fitbit Flex during hospitalization
* Completion of Demographic Data Form at baseline, discharge from hospital, and at the six week clinic visit
* Assist in recording time out of bed using the SCT Daily Activity Log
* Fill out (some with help of parents) applicable questionnaires: Child Health Ratings Inventories-General Health Module (5-12 years), General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years) at baseline, discharge from hospital, and at six week clinic visit
* Patients will be assessed using standard physical therapy assessment tools to determine functioning, muscle strength, endurance, and mobility: The Functional Independence Measure for Children and Manual Muscle Testing is done weekly, discharge from hospital, and at six week clinic visit. The 3-Minute Step Test is done at admission, discharge from hospital, and at six week clinic visit.
3-Minute Step Test
* Using an aerobic step, the participant walks up and down for a given amount of time with the heart rate being checked before and after
* Using the difference in heart rate and a shortness of breath scale, this test is able to give an estimate of aerobic tolerance
HSCT Module-Follow Up Adolescent-Self Report (13-18 years)
* 7 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Child-Self Report (5-12 years)
* 10 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
General Health Module-Baseline Adolescent-Self Report (13-18 years)
* 38 question questionnaire
* Answers range from 1=all of the time to 5=none of the time
General Health Module-Follow Up Adolescent-Self Report (13-18 years)
* 38 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
Demographic Data Form
-16 questions about demographics such as household income, race, and gender
SCT Daily Activity Log
* Uses Fitbit Flex
* Log that lists time in 15 minute increments and allows for checking when out of bed and describing the activity that occurred while out of bed
The Functional Independence Measure for Children
* 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. Three main domains (selfcare, mobility, and cognition) are assessed by interviewing or by observing a child's performance of a task to criterion standards
* Categorized into 2 main functional streams: "Dependent" (ie, requires helper: scores 1-5) and "Independent" (ie, requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belongs to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belongs to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belongs to the "Independent" category.
Manual Muscle Testing
-Isometric muscle strength is tested in specific positions, usually with the muscle at an optimal working length. Using a "break" test, the test giver overpowers the muscle being tested to determine the muscle grade.
Arm 2: Parents of pediatric patients
* Parents will be considered participants as they will be completing study questionnaires.
* Completion of Demographic Data Form at baseline
* Assist in recording time out of bed using the SCT Daily Activity Log
* Fill out applicable questionnaires: General Health Module-Baseline Parent Report -Adolescent (13-18 Years), General Health Module-Follow Up Parent Report-Adolescent (13-18 years), General Health Module-Baseline Parent Report-School Age (5-12 years), and General Health Module Follow Up Parent Report-School Age (5-12 years), HSCT Module-Follow UP Parent Report School Age (5-12 years), HSCT Module-Follow Up Parent Report Adolescent (13-18 years), HSCT Module-Follow Up Adolescent-Self Report (13-18 years), HSCT Module-Follow Child-Self Report (5-12 years) at baseline, discharge from hospital, and at six week clinic visit.
* Assist child with Child Health Ratings Inventories-General Health Module (5-12 years) at baseline, discharge at hospital, and at six week clinic visit
General Health Module-Baseline Parent Report-Adolescent (13-18 years)
* 38 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-Adolescent (13-18 years)
* 38 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Baseline Parent Report-School Age (5-12 years)
* 34 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-School Age (5-12 years)
* 34 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
Demographic Data Form
-16 questions about demographics such as household income, race, and gender
SCT Daily Activity Log
* Uses Fitbit Flex
* Log that lists time in 15 minute increments and allows for checking when out of bed and describing the activity that occurred while out of bed
HSCT Module-Follow Up Parent Report-adolescent (13-18 years)
* 7 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Up Parent Report-School Age (5-12 years)
* 7 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1=all of the time to 5=none of the time
Interventions
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3-Minute Step Test
* Using an aerobic step, the participant walks up and down for a given amount of time with the heart rate being checked before and after
* Using the difference in heart rate and a shortness of breath scale, this test is able to give an estimate of aerobic tolerance
HSCT Module-Follow Up Adolescent-Self Report (13-18 years)
* 7 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Child-Self Report (5-12 years)
* 10 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
General Health Module-Baseline Adolescent-Self Report (13-18 years)
* 38 question questionnaire
* Answers range from 1=all of the time to 5=none of the time
General Health Module-Follow Up Adolescent-Self Report (13-18 years)
* 38 question questionnaire about child
* Answers range from 1=all of the time to 5=none of the time
General Health Module-Baseline Parent Report-Adolescent (13-18 years)
* 38 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-Adolescent (13-18 years)
* 38 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Baseline Parent Report-School Age (5-12 years)
* 34 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-School Age (5-12 years)
* 34 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1-all of the time to 5=none of the time
Demographic Data Form
-16 questions about demographics such as household income, race, and gender
SCT Daily Activity Log
* Uses Fitbit Flex
* Log that lists time in 15 minute increments and allows for checking when out of bed and describing the activity that occurred while out of bed
The Functional Independence Measure for Children
* 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. Three main domains (selfcare, mobility, and cognition) are assessed by interviewing or by observing a child's performance of a task to criterion standards
* Categorized into 2 main functional streams: "Dependent" (ie, requires helper: scores 1-5) and "Independent" (ie, requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belongs to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belongs to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belongs to the "Independent" category.
Manual Muscle Testing
-Isometric muscle strength is tested in specific positions, usually with the muscle at an optimal working length. Using a "break" test, the test giver overpowers the muscle being tested to determine the muscle grade.
HSCT Module-Follow Up Parent Report-adolescent (13-18 years)
* 7 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Up Parent Report-School Age (5-12 years)
* 7 question questionnaire about child
* 49 question questionnaire about parent
* Answers range from 1=all of the time to 5=none of the time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to hospital for stem cell transplant
* Speaks English
* Parents of children ages 7-17 years
* Parents of children admitted to hospital for stem cell transplant
* Speaks English
Exclusion Criteria
7 Years
17 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Heather Taylor, RN, BSN, CPHON
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201406031
Identifier Type: -
Identifier Source: org_study_id
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