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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
• Intervention / Treatment: Other: counseling intervention; Other: educational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity	6 months
Multiple risk factor index	6 months
Knowledge	6 months
Health history taking	3 months
Nutrition	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

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 9, 2007
• First Submitted That Met QC Criteria: April 9, 2007
• First Posted (Estimate): April 11, 2007

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: unspecified childhood solid tumor, protocol specific
• Other Study ID Numbers: CDR0000538178; P30CA051008 (U.S. NIH Grant/Contract); R03CA119686 (U.S. NIH Grant/Contract); GUMC-2006-243