KAM: Kids Are Moving (KAM)

May 23, 2017 updated by: University of Minnesota

KAM: Kids Are Moving; An Exercise Program for Children With Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Childrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical activity measured by FitBit Flex
Time Frame: Change from Baseline, at 2 month, at 4, months, at 6 months
Change from Baseline, at 2 month, at 4, months, at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-report of fatigue
Time Frame: Change from Baseline, at 2 month, at 4, months, at 6 months
Change from Baseline, at 2 month, at 4, months, at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Casey C Hooke, PhD, APRN, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1412M57161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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