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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00459238
First received: April 9, 2007
Last updated: August 13, 2014
Last verified: August 2014
  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
Unspecified Childhood Solid Tumor, Protocol Specific
Other: counseling intervention
Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Multiple risk factor index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health history taking [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Nutrition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tobacco use intentions and behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alcohol use intentions and behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Screening intentions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Perceived benefits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Perceived barriers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: counseling intervention
    subjects will receive telephone based counseling
    Other: educational intervention
    subjects will received telephone based education
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Study Chair: Kenneth Tercyak, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00459238     History of Changes
Other Study ID Numbers: CDR0000538178, R03CA119686, P30CA051008, GUMC-2006-243
Study First Received: April 9, 2007
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
unspecified childhood solid tumor, protocol specific

ClinicalTrials.gov processed this record on October 23, 2014