Overview

This trial is active, not recruiting.

Condition unspecified childhood solid tumor, protocol specific
Treatments counseling intervention, educational intervention
Sponsor Georgetown University
Collaborator National Cancer Institute (NCI)
Start date October 2006
End date July 2016
Trial size 300 participants
Trial identifier NCT00459238, CDR0000538178, GUMC-2006-243, P30CA051008, R03CA119686

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 13 years up to 21 years old.

DISEASE CHARACTERISTICS: - No life-threatening illness (e.g., cancer) - Chronic illnesses (e.g., asthma, diabetes) allowed with permission by physician PATIENT CHARACTERISTICS: - 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 PRIOR CONCURRENT THERAPY: - Not specified

Additional Information

Official title A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
Description OBJECTIVES: Primary - Compare the efficacy of telephone-based cancer education with vs without counseling in younger participants. Secondary - 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Georgetown University.