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

• Sponsor: Georgetown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00459238
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 104
• Location: 1
• Actual Duration (Months): 50
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Childhood Solid Tumor, Protocol Specific	Other: counseling intervention; Other: educational intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
• Actual Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. Multiple risk factor index [6 months]

2. Knowledge [6 months]

3. Health history taking [3 months]

4. Nutrition [6 months]

5. Physical activity [6 months]

6. Tobacco use intentions and behavior [6 months]

7. Alcohol use intentions and behavior [6 months]

8. Screening intentions [6 months]

9. Self-efficacy [6 months]

10. Perceived benefits [6 months]

11. Perceived barriers [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington, D.C.	District of Columbia	United States	20007

Sponsors and Collaborators

• Georgetown University
• National Cancer Institute (NCI)

Investigators

• Study Chair: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georgetown University
• ClinicalTrials.gov Identifier: NCT00459238
• Other Study ID Numbers: CDR0000538178; R03CA119686; P30CA051008; GUMC-2006-243
• First Posted: Apr 11, 2007
• Last Update Posted: May 17, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Georgetown University: unspecified childhood solid tumor, protocol specific

Study Results

No Results Posted as of May 17, 2017