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


N/A
13 Years
21 Years
Open (Enrolling)
Both
Unspecified Childhood Solid Tumor, Protocol Specific

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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 CenterWashington, District of Columbia  20007