NCT00459238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 17, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

April 9, 2007

Last Update Submit

May 16, 2017

Conditions

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (11)

  • Multiple risk factor index

    6 months

  • Knowledge

    6 months

  • Health history taking

    3 months

  • Nutrition

    6 months

  • Physical activity

    6 months

  • Tobacco use intentions and behavior

    6 months

  • Alcohol use intentions and behavior

    6 months

  • Screening intentions

    6 months

  • Self-efficacy

    6 months

  • Perceived benefits

    6 months

  • Perceived barriers

    6 months

Interventions

subjects will receive telephone based counseling

subjects will received telephone based education

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

CounselingEarly Intervention, Educational

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Kenneth Tercyak, PhD

    Lombardi Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

May 17, 2017

Record last verified: 2017-02

Locations