Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Georgetown University Identifier:
First received: April 9, 2007
Last updated: June 26, 2013
Last verified: June 2013

RATIONALE: Telephone-based cancer education and counseling may help participants learn about ways of preventing cancer and choose a lifestyle that will help them stay healthy as they grow older.

PURPOSE: This randomized clinical trial is studying telephone-based cancer education and telephone-based counseling to see how well they work compared with telephone-based cancer education alone in young participants.

Condition Intervention
Unspecified Childhood Solid Tumor, Protocol Specific
Other: counseling intervention
Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Multiple risk factor index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health history taking [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Nutrition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tobacco use intentions and behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alcohol use intentions and behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Screening intentions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Perceived benefits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Perceived barriers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: counseling intervention
    subjects will receive telephone based counseling
    Other: educational intervention
    subjects will received telephone based education
Detailed Description:



  • Compare the efficacy of telephone-based cancer education with vs without counseling in younger participants.


  • Determine the mechanisms by which education with counseling may impact cancer-relevant cognitive and behavioral outcomes.
  • Identify teens who may be most and least likely to benefit from education with counseling.

OUTLINE: This is a pilot, controlled, randomized study. Participants are stratified according to age (13-14 years vs 15 years vs 16 years vs 17 years vs 18-21 years), gender, race (white vs black vs other), and health status (chronic disease vs no chronic disease). Participants are randomized to 1 of 2 education arms.

  • Arm I: Participants undergo cancer education sessions via telephone over 45 minutes once a week for 8 weeks.
  • Arm II: Participants under cancer education sessions as in arm I and counseling techniques during the same telephone sessions.

In both arms, participants receive an intervention kit by mail before the first telephone call. The intervention kit includes age-appropriate self-help materials.

PROJECTED ACCRUAL: A total of 300 participants will be accrued for this study.


Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes


  • No life-threatening illness (e.g., cancer)

    • Chronic illnesses (e.g., asthma, diabetes) allowed with permission by physician


  • No serious restrictions on physical activity, diet, or nutrition, including any of the following:

    • Untreated exercise-induced asthma
    • Orthopedic or neurological problems
    • Medical conditions affecting nutritional status, intestinal absorption, or response to nutritional intervention (e.g., inflammatory bowel disease)
  • No serious mental illness or developmental disability that would preclude study compliance, including eating disorders
  • Must adequately understand, speak, and read English


  • Not specified
  Contacts and Locations
Please refer to this study by its identifier: NCT00459238

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Study Chair: Kenneth Tercyak, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Georgetown University Identifier: NCT00459238     History of Changes
Other Study ID Numbers: CDR0000538178, R03CA119686, P30CA051008, GUMC-2006-243
Study First Received: April 9, 2007
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
unspecified childhood solid tumor, protocol specific processed this record on April 16, 2014