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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459238
First Posted: April 11, 2007
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Multiple risk factor index [ Time Frame: 6 months ]
  • Knowledge [ Time Frame: 6 months ]
  • Health history taking [ Time Frame: 3 months ]
  • Nutrition [ Time Frame: 6 months ]
  • Physical activity [ Time Frame: 6 months ]
  • Tobacco use intentions and behavior [ Time Frame: 6 months ]
  • Alcohol use intentions and behavior [ Time Frame: 6 months ]
  • Screening intentions [ Time Frame: 6 months ]
  • Self-efficacy [ Time Frame: 6 months ]
  • Perceived benefits [ Time Frame: 6 months ]
  • Perceived barriers [ Time Frame: 6 months ]

Enrollment: 104
Actual Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459238


Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
Study Chair: Kenneth Tercyak, PhD Lombardi Comprehensive Cancer Center
  More Information

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00459238     History of Changes
Other Study ID Numbers: CDR0000538178
R03CA119686 ( U.S. NIH Grant/Contract )
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-2006-243
First Submitted: April 9, 2007
First Posted: April 11, 2007
Last Update Posted: May 17, 2017
Last Verified: February 2017

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