Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
|ClinicalTrials.gov Identifier: NCT00459238|
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : May 17, 2017
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 or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Other: counseling intervention Other: educational intervention||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Telephone-Based Education and Prevention Intervention for Teens and Young Adults|
|Actual Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Other: counseling intervention
- Multiple risk factor index [ Time Frame: 6 months ]
- Knowledge [ Time Frame: 6 months ]
- Health history taking [ Time Frame: 3 months ]
- Nutrition [ Time Frame: 6 months ]
- Physical activity [ Time Frame: 6 months ]
- Tobacco use intentions and behavior [ Time Frame: 6 months ]
- Alcohol use intentions and behavior [ Time Frame: 6 months ]
- Screening intentions [ Time Frame: 6 months ]
- Self-efficacy [ Time Frame: 6 months ]
- Perceived benefits [ Time Frame: 6 months ]
- Perceived barriers [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459238
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, D.C., District of Columbia, United States, 20007|
|Study Chair:||Kenneth Tercyak, PhD||Lombardi Comprehensive Cancer Center|