Group Intervention to Increase Physical Activity in Childhood Cancer Survivors

Pediatric Cancer Clinical Trial

Official title:

Group Intervention to Increase Physical Activity in Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835509
• Other study ID #: J12136
• Status: Completed
• Phase: Phase 0
• First received: April 11, 2013
• Last updated: February 24, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Cancer survivors ages 8-12 years.

2. Off therapy for at least 3 months and not more than 5 years and in remission.

3. Medical clearance to participate in physical activities from the survivor's primary oncology provider;

4. Self-report of < 60 minutes of moderate to vigorous physical activity (MVPA) per day.

5. Must be able to ambulate.

6. Signed informed consent/assent.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Intervention, Camp plus reunions

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Self efficacy	Self efficacy is measured with a questionnaire	Change in self efficacy measrued prestudy and 6 months after camp	No