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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Telephone-Based Education and Prevention Intervention for Teens and Young Adults

Conditions
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Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: counseling intervention
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|subjects will receive telephone based counseling|
|Other: educational intervention|subjects will received telephone based education|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple risk factor index |  | 6 months | 
| Knowledge |  | 6 months | 
| Health history taking |  | 3 months | 
| Nutrition |  | 6 months | 
| Physical activity |  | 6 months | 
| Tobacco use intentions and behavior |  | 6 months | 
| Alcohol use intentions and behavior |  | 6 months | 
| Screening intentions |  | 6 months | 
| Self-efficacy |  | 6 months | 
| Perceived benefits |  | 6 months | 
| Perceived barriers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified childhood solid tumor, protocol specific