A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
13 Years
21 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Multiple risk factor index
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Kenneth Tercyak, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Lombardi Cancer Research Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000538178
NCT ID:
NCT00459238
Start Date:
October 2006
Completion Date:
December 2014
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
Name | Location |
|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
