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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00459238
Enrollment
104
Registered
2007-04-11
Start date
2006-10-31
Completion date
2010-12-31
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Brief 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.

Detailed 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.

Interventions

OTHERcounseling intervention

subjects will receive telephone based counseling

OTHEReducational intervention

subjects will received telephone based education

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Multiple risk factor index6 months
Knowledge6 months
Health history taking3 months
Nutrition6 months
Physical activity6 months
Tobacco use intentions and behavior6 months
Alcohol use intentions and behavior6 months
Screening intentions6 months
Self-efficacy6 months
Perceived benefits6 months
Perceived barriers6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026