Hematopoietic and Stem Cell Transplant
Conditions
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.
Interventions
OTHERGeneral 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
OTHERGeneral 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
OTHERGeneral 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
OTHERGeneral 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
OTHERHSCT 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
OTHERHSCT 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
OTHERGeneral 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
OTHERGeneral 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
OTHERDemographic Data Form
-16 questions about demographics such as household income, race, and gender
OTHERSCT 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
OTHERThe 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.
-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.
OTHER3-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
OTHERHSCT 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
OTHERHSCT 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
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment and retention of participants throughout the study | Baseline through 6 week clinic visit (up to an estimated 82 days) | -Analyze the number of participants enrolled who continue through the 6 week clinic visit |
| 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) | — |
Countries
United States
Outcome results
None listed