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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459238
• Other study ID #: CDR0000538178
• Secondary ID: R03CA119686P30CA
• Status: Completed
• Phase: N/A
• First received: April 9, 2007
• Last updated: May 16, 2017
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: February 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Other:
• counseling intervention
subjects will receive telephone based counseling
• educational intervention
subjects will received telephone based education

Locations

Country	Name	City	State
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple risk factor index		6 months
Primary	Knowledge		6 months
Primary	Health history taking		3 months
Primary	Nutrition		6 months
Primary	Physical activity		6 months
Primary	Tobacco use intentions and behavior		6 months
Primary	Alcohol use intentions and behavior		6 months
Primary	Screening intentions		6 months
Primary	Self-efficacy		6 months
Primary	Perceived benefits		6 months
Primary	Perceived barriers		6 months