Unspecified Childhood Solid Tumor, Protocol SpecificNCT00459238
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
A study testing counseling intervention and educational intervention in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- counseling intervention and educational intervention
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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 locations and contacts
1 site in 1 country.
United States1 site
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
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.
Read the 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.
- Being tested
- counseling intervention, educational intervention
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
subjects will receive telephone based counseling
educational interventionOther
subjects will received telephone based education
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple risk factor index
Measured: 6 months
Knowledge
Measured: 6 months
Health history taking
Measured: 3 months
Nutrition
Measured: 6 months
Physical activity
Measured: 6 months
Tobacco use intentions and behavior
Measured: 6 months
Alcohol use intentions and behavior
Measured: 6 months
Screening intentions
Measured: 6 months
Self-efficacy
Measured: 6 months
Perceived benefits
Measured: 6 months
Perceived barriers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kenneth Tercyak, PhD, Study chair, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459238
- Sponsor's protocol ID
- CDR0000538178
- Other IDs
- R03CA119686, P30CA051008, GUMC-2006-243
- Status last verified
- Feb 2017
- First submitted
- 9 Apr 2007
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
- ClinicalTrials.gov ID
- NCT00459238
- Acronym / sponsor ID
- CDR0000538178
- Keywords
- unspecified childhood solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2006 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling interventionsubjects will receive telephone based counseling | Other | – |
| educational interventionsubjects will received telephone based education | Other | – |
Primary outcome
Multiple risk factor index
Time frame: 6 months
Knowledge
Time frame: 6 months
Health history taking
Time frame: 3 months
Nutrition
Time frame: 6 months
Physical activity
Time frame: 6 months
Tobacco use intentions and behavior
Time frame: 6 months
Alcohol use intentions and behavior
Time frame: 6 months
Screening intentions
Time frame: 6 months
Self-efficacy
Time frame: 6 months
Perceived benefits
Time frame: 6 months
Perceived barriers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Tercyak, PhD study chair
Lombardi Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention and educational intervention in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple risk factor index (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.