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KAM: Kids Are Moving (KAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626637
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE December 10, 2015
Last Update Posted Date May 24, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
Physical activity measured by FitBit Flex [ Time Frame: Change from Baseline, at 2 month, at 4, months, at 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
Self-report of fatigue [ Time Frame: Change from Baseline, at 2 month, at 4, months, at 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KAM: Kids Are Moving
Official Title  ICMJE KAM: Kids Are Moving; An Exercise Program for Children With Cancer
Brief Summary

During cancer treatment children are less active than their health peers. This inactivity persists into survivorship and can negatively affect health and quality of life. Physical activity may also improve fatigue, a prevalent and distressing symptom during treatment. Improving health behaviors during treatment can have lifelong benefits for cancer survivors. In this study, the effectiveness of the "Kids are Moving" exercise program will be evaluated. The exercise program will follow program guidelines set up by the American College of Sports Medicine and will be adapted for children with cancer. Children ages 6 to 18 years, who are receiving chemotherapy, and their parents, will be coached on how to increase their physical activity and will receive an exercise prescription. This will occur as part of the standard care they receive from the nurse practitioners during the first six months of their outpatient visits. Investigators want to find out if children in the Kids are Moving program are more active and have less fatigue. Activity will be measured through patient questionnaires about activity and fatigue, and by wearing the FitBit activity tracker and an actigraph. Outcomes will be compared to measurements collected from children who received usual care before the exercise program started.

Physical activity is a vital for improving health and quality of life and for providing energy for engaging in positive life experiences as children move along the developmental continuum to a long and healthy future. Outcomes of the study will provide a foundation for larger multi-site clinical trials.

Detailed Description

During cancer treatment children are significantly less active than their healthy peers. This inactivity persists into survivorship, negatively influencing their health and quality of life. Physical activity may also improve fatigue, a near-universal and distressing symptom during treatment. Improving health behaviors during treatment can have lifelong benefit.

The goal of this study is to evaluate the effectiveness of the Kids are Moving exercise program that is delivered by nurse practitioners (NP's) during outpatient care provided to a specific population of children. The study will be conducted at two pediatric cancer treatment sites and will translate the American College of Sports Medicine's program, Exercise is Medicine into practice. In this quasi-experimental design, children will receive the study intervention, which includes exercise coaching and prescription, that is be incorporated into the standard care they receive from the nurse practitioners during their outpatient visits. Outcomes will be compared to historical control measurements of children who received usual care. Study aims are to:

  1. To compare measurements of activity levels of children receiving exercise coaching over the first 6 months of cancer treatment as measured by self-report and the FitBit Flex tracker
  2. To compare activity levels of children receiving exercise coaching during cancer treatment as measured by self-report and the FitBit Flex tracker, to activity levels of children in the historical control group receiving usual care during cancer treatment.
  3. To evaluate the influence of activity levels on fatigue experience by children receiving cancer treatment

Children ages 6 to 18, and their parents, will be invited to participate in study measurements which will be completed at the 2nd, 4th, and 6th months of cancer treatment. Patients will be included if recently diagnosed with cancer (excluding bone tumors and bone metastasis), and ambulatory. Validated self-report instruments will be used to measure activity and fatigue. Additionally, the FitBit Flex tracker, a device that measures steps/day and motion in three dimensions and an actigraph, will be worn by subjects over a 3 day period for each measurement point.

Physical activity is a vital intervention for improving health and quality of life and for providing energy for engaging in positive life experiences that advance children along the developmental continuum to a long and healthy future. Outcomes of the study will provide a foundation for larger multi-site clinical trials.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Children With Cancer
  • Fatigue
  • Physical Activity
Intervention  ICMJE Other: Physical activity coaching
Children and adolescents will receive the study intervention, which includes exercise coaching and prescription, that is be incorporated into the standard care they receive from the nurse practitioners during their outpatient visits.
Study Arms  ICMJE Experimental: Physical activity coaching
Children and adolescents will receive the study intervention, which includes exercise coaching and prescription, that is be incorporated into the standard care they receive from the nurse practitioners during their outpatient visits.
Intervention: Other: Physical activity coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2015)
40
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. between the ages of 6 and 18 with any cancer diagnosis except for bone tumors or have bone metastasis
  2. have received cancer treatment that includes chemotherapy for at least 2 months, have outpatient visits at least once a month, and are ambulatory
  3. speak English
  4. are able to give assent according to institutional guidelines
  5. have parental consent to participate.

Exclusion Criteria:

1. Not meeting inclusion criteria

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02626637
Other Study ID Numbers  ICMJE 1412M57161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Casey C Hooke, PhD, APRN University of Minnesota
PRS Account University of Minnesota
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP