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

NCT ID: NCT00459238

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-12-31

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

counseling intervention

subjects will receive telephone based counseling

Intervention Type: OTHER

educational intervention

subjects will received telephone based education

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Tercyak, PhD

Role: STUDY_CHAIR

Lombardi Comprehensive Cancer Center

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

R03CA119686

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA051008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GUMC-2006-243

Identifier Type: -

Identifier Source: secondary_id

CDR0000538178

Identifier Type: -

Identifier Source: org_study_id