Deconditioning in Transplant

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.

Conditions

• Hematopoietic and Stem Cell Transplant

Interventions

OTHER

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

OTHER

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

OTHER

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

OTHER

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

OTHER

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

OTHER

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

OTHER

Demographic Data Form

-16 questions about demographics such as household income, race, and gender

OTHER

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

OTHER

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.

OTHER

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.

OTHER

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

OTHER

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

OTHER

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

OTHER

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

OTHER

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

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Heather Taylor, RN, BSN, CPHON · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• United States

Study Locations