Clinical trial NCT00459238: Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
Official title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: unspecified childhood solid tumor, protocol specific
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-11
Enrollment: 104
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Multiple risk factor index
timeFrame: 6 months
measure: Knowledge
timeFrame: 6 months
measure: Health history taking
timeFrame: 3 months
measure: Nutrition
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Tobacco use intentions and behavior
timeFrame: 6 months
measure: Alcohol use intentions and behavior
timeFrame: 6 months
measure: Screening intentions
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 6 months
measure: Perceived benefits
timeFrame: 6 months
measure: Perceived barriers
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Kenneth Tercyak, PhD
role: STUDY_CHAIR
References: