Hematopoietic and Stem Cell TransplantEarly Phase 1NCT02611219
Deconditioning in Transplant
A Early Phase 1 study testing General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years) and General Health Module-Baseline Parent Report-Adolescent (13-18 years) in people with Hematopoietic and Stem Cell Transplant, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Hematopoietic and Stem Cell Transplant
- What is being tested?
- General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years) and General Health Module-Baseline Parent Report-Adolescent (13-18 years)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
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
- Being tested
- General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years), 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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
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
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
Demographic Data FormOther
-16 questions about demographics such as household income, race, and gender
SCT Daily Activity LogOther
- 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 ChildrenOther
Also called WeeFIM
- 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 TestingOther
Also called MMT
-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.
3-Minute Step TestOther
- 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)Other
- 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)Other
- 10 question questionnaire about child
- Answers range from 1=all of the time to 5=none of the time
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention of participants throughout the study
-Analyze the number of participants enrolled who continue through the 6 week clinic visit
Measured: 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
Measured: Baseline through 6 week clinic visit (up to an estimated 82 days)
Quality of life as measured by General Health Module questionnaires
Measured: Discharge from hospital (estimated to be 40 days)
Quality of life as measured by General Health Module questionnaires
Measured: Baseline through 6 week clinic visit (up to an estimated 82 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Taylor, RN, BSN, CPHON, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611219
- Sponsor's protocol ID
- 201406031
- Status last verified
- May 2016
- First submitted
- 12 Nov 2015
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02611219
- Acronym / sponsor ID
- 201406031
- Conditions
- Hematopoietic and Stem Cell Transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pediatric patients | Experimental | 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)* 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. |
| Arm 2: Parents of pediatric patients | Experimental | 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)* 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 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm 1: Pediatric patients |
| 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 | Arm 1: Pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
| Demographic Data Form-16 questions about demographics such as household income, race, and gender | Other | Arm 1: Pediatric patients, Arm 2: Parents of pediatric patients |
| 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 | Arm 1: Pediatric patients, Arm 2: Parents of pediatric patients |
| The Functional Independence Measure for ChildrenAlso: WeeFIM* 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 | Arm 1: Pediatric patients |
| Manual Muscle TestingAlso: MMT-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 | Arm 1: Pediatric patients |
| 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 | Arm 1: Pediatric patients |
| 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 | Arm 1: Pediatric patients |
| 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 | Arm 1: Pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
| 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 | Arm 2: Parents of pediatric patients |
Primary outcome
Recruitment and retention of participants throughout the study
Time frame: 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
Time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)
Quality of life as measured by General Health Module questionnaires
Time frame: Discharge from hospital (estimated to be 40 days)
Quality of life as measured by General Health Module questionnaires
Time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Taylor, RN, BSN, CPHON principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years) and General Health Module-Baseline Parent Report-Adolescent (13-18 years) in people with Hematopoietic and Stem Cell Transplant, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention of participants throughout the study (time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.