KAM: Kids Are Moving

Physical Activity Clinical Trial

— KAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626637
• Other study ID #: 1412M57161
• Status: Completed
• Phase: N/A
• First received: November 25, 2015
• Last updated: May 23, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children With Cancer
• Fatigue
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Minnesota	Minneapolis	Minnesota
United States	University of Minnesota Masonic Childrens	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity measured by FitBit Flex		Change from Baseline, at 2 month, at 4, months, at 6 months
Secondary	Self-report of fatigue		Change from Baseline, at 2 month, at 4, months, at 6 months