Deconditioning in Transplant

NCT02611219 | Completed Early Phase 1

• 1 other identifier: 201406031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Stem Cell Transplant

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Arm 1: Pediatric patients

EXPERIMENTAL

* 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); Other: General Health Module-Follow Up Adolescent-Self Report (13-18 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)

Arm 2: Parents of pediatric patients

EXPERIMENTAL

* 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); 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: HSCT Module-Follow Up Parent Report-adolescent (13-18 years); Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years)

Interventions

General Health Module-Baseline Adolescent-Self Report (13-18 years) OTHER

* 38 question questionnaire * Answers range from 1=all of the time to 5=none of the time

Arm 1: Pediatric patients

General Health Module-Follow Up Adolescent-Self Report (13-18 years) OTHER

* 38 question questionnaire about child * Answers range from 1=all of the time to 5=none of the time

Arm 1: Pediatric patients

General Health Module-Baseline Parent Report-Adolescent (13-18 years) OTHER

* 38 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1-all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

General Health Module-Follow Up Parent Report-Adolescent (13-18 years) OTHER

* 38 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1-all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

General Health Module-Baseline Parent Report-School Age (5-12 years) OTHER

* 34 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1-all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

General Health Module-Follow Up Parent Report-School Age (5-12 years) OTHER

* 34 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1-all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

Demographic Data Form OTHER

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

Arm 1: Pediatric patients; Arm 2: Parents of pediatric patients

SCT Daily Activity Log OTHER

* 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

Arm 1: Pediatric patients; Arm 2: Parents of pediatric patients

The Functional Independence Measure for Children OTHER

* 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.

Also known as: WeeFIM

Arm 1: Pediatric patients

Manual Muscle Testing OTHER

-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.

Also known as: MMT

Arm 1: Pediatric patients

3-Minute Step Test OTHER

* 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

Arm 1: Pediatric patients

HSCT Module-Follow Up Adolescent-Self Report (13-18 years) OTHER

* 7 question questionnaire about child * Answers range from 1=all of the time to 5=none of the time

Arm 1: Pediatric patients

HSCT Module-Follow Child-Self Report (5-12 years) OTHER

* 10 question questionnaire about child * Answers range from 1=all of the time to 5=none of the time

Arm 1: Pediatric patients

HSCT Module-Follow Up Parent Report-adolescent (13-18 years) OTHER

* 7 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1=all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

HSCT Module-Follow Up Parent Report-School Age (5-12 years) OTHER

* 7 question questionnaire about child * 49 question questionnaire about parent * Answers range from 1=all of the time to 5=none of the time

Arm 2: Parents of pediatric patients

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 7-17 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

2-methylcyclopentadienyl manganese tricarbonyl; Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Heather Taylor, RN, BSN, CPHON

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 20, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)