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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBehavioral study, Health services researchCompleted7 to 18OtherR21 CA128019
NCT01171599

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Rebecca and John Moores UCSD Cancer Center

Kevin Patrick, MD, MSPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01171599
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.