Deconditioning in Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this feasibility study is to test the potential for successful implementation of an intervention designed to study the effect of six hours out of bed time on the overall level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research has demonstrated that deconditioning occurs rapidly over the course of the hospitalization post-transplant and can negatively impact quality of life. By encouraging patients to be out of bed for six hours each day, it is anticipated that patients will experience less deconditioning than those patients who previously had no established minimum time out of the bed.

Official Title
-----------------
Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study

Conditions
-----------------
Hematopoietic and Stem Cell Transplant

Intervention / Treatment
-----------------
* Other: General Health Module-Baseline Adolescent-Self Report (13-18 years)
* Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years)
* Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years)
* Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years)
* Other: General Health Module-Baseline Parent Report-School Age (5-12 years)
* Other: General Health Module-Follow Up Parent Report-School Age (5-12 years)
* Other: Demographic Data Form
* Other: SCT Daily Activity Log
* Other: The Functional Independence Measure for Children
* Other: Manual Muscle Testing
* Other: 3-Minute Step Test
* Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years)
* Other: HSCT Module-Follow Child-Self Report (5-12 years)
* Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years)
* Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Pediatric Patients) Ages 7-17 years Admitted to hospital for stem cell transplant Speaks English Inclusion Criteria (Parents of pediatric patients) Parents of children ages 7-17 years Parents of children admitted to hospital for stem cell transplant Speaks English Exclusion Criteria (Pediatric Patients) -Admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included Exclusion Criteria (Parents of pediatric patients) -Parents of children admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pediatric patients<br>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. | Other: General Health Module-Baseline Adolescent-Self Report (13-18 years)<br>* 38 question questionnaire Answers range from 1=all of the time to 5=none of the time<br>Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years)<br>* 38 question questionnaire about child Answers range from 1=all of the time to 5=none of the time<br>Other: Demographic Data Form<br>* -16 questions about demographics such as household income, race, and gender<br>Other: SCT Daily Activity Log<br>* 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<br>Other: The Functional Independence Measure for Children<br>* 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.<br>* Other names: WeeFIM;Other: Manual Muscle Testing<br>* -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.<br>* Other names: MMT;Other: 3-Minute Step Test<br>* 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<br>Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years)<br>* 7 question questionnaire about child Answers range from 1=all of the time to 5=none of the time<br>Other: HSCT Module-Follow Child-Self Report (5-12 years)<br>* 10 question questionnaire about child Answers range from 1=all of the time to 5=none of the time<br>|
| Experimental: Arm 2: Parents of pediatric patients<br>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 | Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years)<br>* 38 question questionnaire about child 49 question questionnaire about parent Answers range from 1-all of the time to 5=none of the time<br>Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years)<br>* 38 question questionnaire about child 49 question questionnaire about parent Answers range from 1-all of the time to 5=none of the time<br>Other: General Health Module-Baseline Parent Report-School Age (5-12 years)<br>* 34 question questionnaire about child 49 question questionnaire about parent Answers range from 1-all of the time to 5=none of the time<br>Other: General Health Module-Follow Up Parent Report-School Age (5-12 years)<br>* 34 question questionnaire about child 49 question questionnaire about parent Answers range from 1-all of the time to 5=none of the time<br>Other: Demographic Data Form<br>* -16 questions about demographics such as household income, race, and gender<br>Other: SCT Daily Activity Log<br>* 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<br>Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years)<br>* 7 question questionnaire about child 49 question questionnaire about parent Answers range from 1=all of the time to 5=none of the time<br>Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years)<br>* 7 question questionnaire about child 49 question questionnaire about parent Answers range from 1=all of the time to 5=none of the time<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and retention of participants throughout the study | -Analyze the number of participants enrolled who continue through the 6 week clinic visit | Baseline through 6 week clinic visit (up to an estimated 82 days) | 
| Number of participants who achieve 6 hours out of bed through the 6 week clinic visit |  | Baseline through 6 week clinic visit (up to an estimated 82 days) | 
| Quality of life as measured by General Health Module questionnaires |  | Discharge from hospital (estimated to be 40 days) | 
| Quality of life as measured by General Health Module questionnaires |  | Baseline through 6 week clinic visit (up to an estimated 82 days) |