KAM: Kids Are Moving
KAM
1 other identifier
interventional
31
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 24, 2017
May 1, 2017
1.5 years
November 25, 2015
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity measured by FitBit Flex
Change from Baseline, at 2 month, at 4, months, at 6 months
Secondary Outcomes (1)
Self-report of fatigue
Change from Baseline, at 2 month, at 4, months, at 6 months
Study Arms (1)
Physical activity coaching
EXPERIMENTALChildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- between the ages of 6 and 18 with any cancer diagnosis except for bone tumors or have bone metastasis
- have received cancer treatment that includes chemotherapy for at least 2 months, have outpatient visits at least once a month, and are ambulatory
- speak English
- are able to give assent according to institutional guidelines
- have parental consent to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Minnesota
Minneapolis, Minnesota, 55404, United States
University of Minnesota Masonic Childrens
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Casey C Hooke, PhD, APRN
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 10, 2015
Study Start
November 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 24, 2017
Record last verified: 2017-05