PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia (PACE-CALL)
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|ClinicalTrials.gov Identifier: NCT01171599|
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : June 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Weight Loss Weight Maintenance||Behavioral: Fit4Life||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- 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:
- Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups [ Time Frame: 2-hour focus group ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171599
|United States, California|
|UCSD, Atkinson Hall, 3rd Floor|
|La Jolla, California, United States, 92037-0811|
|Principal Investigator:||Kevin Patrick, MD, MS||UCSD|