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

Sponsors and Collaborators:	Lombardi Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00459238

Purpose

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
Healthy, no Evidence of Disease	Procedure: counseling Procedure: educational intervention

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	A Telephone-Based Education and Prevention Intervention for Teens and Young Adults

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Multiple risk factor index [ Designated as safety issue: No ]
Knowledge [ Designated as safety issue: No ]
Health history taking [ Designated as safety issue: No ]
Nutrition [ Designated as safety issue: No ]
Physical activity [ Designated as safety issue: No ]
Tobacco use intentions and behavior [ Designated as safety issue: No ]
Alcohol use intentions and behavior [ Designated as safety issue: No ]
Screening intentions [ Designated as safety issue: No ]
Self-efficacy [ Designated as safety issue: No ]
Perceived benefits [ Designated as safety issue: No ]
Perceived barriers [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2006
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459238

Locations

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381

Sponsors and Collaborators

Lombardi Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Kenneth Tercyak, PhD

Lombardi Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000538178, GUMC-2006-243
Study First Received:	April 9, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00459238
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

healthy, no evidence of disease

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009