Clinical trial NCT01171599: PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
Official title: PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Weight Maintenance
Keywords: Weight Loss
Obesity
Overweight
Physical Activity
Nutrition
Youth
Adolescent
Technology
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups
timeFrame: 2-hour focus group
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD, Atkinson Hall, 3rd Floor
state: California
Study officials:
affiliation: UCSD
name: Kevin Patrick, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: