PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01171599
First received: July 23, 2010
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Behavioral: Fit4Life
    As previously described, the purpose of this study is to develop a web and text message based weight loss intervention for childhood acute lymphoblastic leukemia survivors (ALL) survivor. The web and text message based intervention that is being developed will be evaluated in a separate ACS (American Cancer Society) funded trial randomized control trial. The web and text message based intervention (there are other intervention features that do not relate to the web & text based platforms that were developed as part of this NIH funded study) is a 16-week program that includes:
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

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171599

Locations
United States, California
UCSD, Atkinson Hall, 3rd Floor
La Jolla, California, United States, 92037-0811
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kevin Patrick, MD, MS UCSD
  More Information

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:
Leukemia
Obesity
Weight Loss
Overweight
Neoplasms by Histologic Type
Neoplasms
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 23, 2014