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

Georgetown University

Status: Completed

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Other: educational intervention; Other: counseling intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00459238

P30CA051008 (U.S. NIH Grant/Contract)

GUMC-2006-243

CDR0000538178

R03CA119686 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)