Group Intervention to Increase Physical Activity in Childhood Cancer Survivors
1 other identifier
interventional
20
1 country
1
Brief Summary
The primary aim of this randomized, controlled study is to evaluate the impact and feasibility of a prolonged physical activity intervention in school-aged childhood cancer survivors who self-report sedentary lifestyles. The study will test the hypothesis that childhood cancer survivors participating in a physical activity intervention guided by Social Cognitive Theory will increase the amount of time spent daily in moderate to vigorous physical activity, and improve exercise self-efficacy compared to children randomized to usual care. A secondary aim is to assess the impact of the intervention on cardiovascular risk factors including fitness and body composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2013
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 11, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 25, 2014
February 1, 2014
1 year
April 11, 2013
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in level of physical activity
Physical activity will be measured with Accelerometers worn for 4 days pre-study and six months later
change from pre-study and at 6months after camp
Secondary Outcomes (1)
Change in Self efficacy
Change in self efficacy measrued prestudy and 6 months after camp
Study Arms (2)
Intervention, Camp + Reunions
EXPERIMENTAL5 day , day camp plus 5 monthly reunions
Control, Newsletters
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Cancer survivors ages 8-12 years.
- Off therapy for at least 3 months and not more than 5 years and in remission.
- Medical clearance to participate in physical activities from the survivor's primary oncology provider;
- Self-report of \< 60 minutes of moderate to vigorous physical activity (MVPA) per day.
- Must be able to ambulate.
- Signed informed consent/assent.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Related Publications (1)
Ruble K, Scarvalone S, Gallicchio L, Davis C, Wells D. Group Physical Activity Intervention for Childhood Cancer Survivors: A Pilot Study. J Phys Act Health. 2016 Mar;13(3):352-9. doi: 10.1123/jpah.2015-0050. Epub 2015 Aug 13.
PMID: 26284383DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2013
First Posted
April 19, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 25, 2014
Record last verified: 2014-02