PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
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The purpose of this National Cancer Institute (NCI) funded study is to develop and test the acceptability and usability of a web & text message based weight loss intervention for childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 - 18 will provide feedback during focus groups on a web and text message based program that was developed.
Condition | Intervention |
---|---|
Obesity Overweight Weight Loss Weight Maintenance |
Behavioral: Fit4Life |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia |
- Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups [ Time Frame: 2-hour focus group ] [ Designated as safety issue: No ]The primary outcome is to develop a web and text message based weight loss intervention that will provide individual assessment and tailoring of a behavioral intervention for ALL survivors. In order to test the acceptaibility and usability of the website and text message program, focus groups will be conducted with cancer survivors to provide feedback on the program.
Enrollment: | 12 |
Study Start Date: | August 2008 |
Study Completion Date: | August 2011 |
Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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Behavioral: Fit4Life
This is a two year study to develop a predominantly web-based behavioral assessment and intervention program (PACE-CALL) that will provide individual assessment and tailoring of a behavioral intervention for adolescent children Acute Lymphoblastic Leukemia (ALL) survivors and their families. In addition, we are conducting formative research to adapt the abovementioned program to children and adolescents aged 7 - 18 who survived any cancer.
Focus Groups: Web-Based & Text Message Intervention Feedback
Two focus groups will be conducted with adolescent cancer survivors and their families, to assess the usability and acceptability of the web-based intervention, focus groups will be conducted. The two focus groups will last 2 hours with 6-8 people in each group: one focus group with youth & adolescents (age 7 - 18 who are representative of the target population to determine the appropriateness of the web-based intervention one focus group with the parents of the children in the focus group mentioned above (it will occur at the same time). All focus groups will begin with an overview of the study and description of the web-based intervention components. Focus group participants will see sample web pages and may be asked to provide feedback on some or all of the following:
Youth, Adolescent or Parent:
- How does the web-based and text message based intervention address issues faced by children who have survived cancer?
- What do you like about the web-based intervention? What do you not like about the web-based intervention? What would you change about the web-based intervention?
- What do you like about the text messages? What do you not like about the text messages?
- Would you want to join a program like this? Why or why not?
- If you were to be in this program, how often would you log on to the web-based intervention? How often would you want to receive text messages?
- What are some of the barriers to joining a program like this?
Ages Eligible for Study: | 7 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are 7 - 18 years
- Provide assent and have a legal guardian that will participate and provide parental permission/consent
- Are a cancer survivor (off treatment for two years)
- Are overweight or obese (85th percentile BMI (Body Mass Index) for age and gender)
Exclusion Criteria:
- Have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
United States, California | |
UCSD, Atkinson Hall, 3rd Floor | |
La Jolla, California, United States, 92037-0811 |
Principal Investigator: | Kevin Patrick, MD, MS | UCSD |
Additional Information:
No publications provided
Responsible Party: | Kevin Patrick, MD, MS, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01171599 History of Changes |
Other Study ID Numbers: | R21 CA128019 |
Study First Received: | July 23, 2010 |
Last Updated: | June 8, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
Weight Loss Obesity Overweight Physical Activity |
Nutrition Youth Adolescent Technology |
Additional relevant MeSH terms:
Body Weight Leukemia Obesity Weight Loss Overweight Signs and Symptoms |
Neoplasms by Histologic Type Neoplasms Overnutrition Nutrition Disorders Body Weight Changes |
ClinicalTrials.gov processed this record on October 17, 2012