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Completed

NCT Number: NCT00459238

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

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.

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Key information

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

subjects will receive telephone based counseling

Educational Intervention

Other

subjects will received telephone based education

Primary outcomes

  1. Multiple risk factor index

    Time frame: 6 months

  2. Knowledge

    Time frame: 6 months

  3. Health history taking

    Time frame: 3 months

  4. Nutrition

    Time frame: 6 months

  5. Physical activity

    Time frame: 6 months

  6. Tobacco use intentions and behavior

    Time frame: 6 months

  7. Alcohol use intentions and behavior

    Time frame: 6 months

  8. Screening intentions

    Time frame: 6 months

  9. Self-efficacy

    Time frame: 6 months

  10. Perceived benefits

    Time frame: 6 months

  11. Perceived barriers

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Apr 11, 2007
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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