- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948337
A Study With Health Educational Material on Health Promotion in Cancer Survivors
February 25, 2010 updated by: National Cancer Center, Korea
A Randomized Controlled Trial on the Effect of Intervention With Health Educational Material on Knowledge, Attitude, and Behavior in Cancer Survivors
The purpose of this study is to provide educational material to promote screening for second primary cancer for the intervention group, or educational material to instruct appropriate use of dietary supplement for the control group.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
326
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Gyeonggi
-
Goyang, Gyeonggi, Korea, Republic of, 410-769
- National Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >=18, <80
- Cancer survivors (pathologically confirmed)
- Finished primary treatment (surgery, radiotherapy, chemotherapy)
- >= 1 year from cancer diagnosis
- No evidence of recurrence, metastasis, and second primary cancer
- No evidence of hereditary cancer
- ECOG 0,1,2
- Ability in reading Korean educational material
Exclusion Criteria:
- ECOG 3,4
- Disagree with the investigators study purpose
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Photonovella of Secondary Cancer Screening
|
One kind of printed educational material
|
|
Active Comparator: Photonovella of Dietary Suppelment of Cancer survivor
|
One kind of printed educational material
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Screening behavior for second primary cancer
Time Frame: After 1 yr
|
After 1 yr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Knowledge and attitudes of Secondary cancer screening and dietary supplement
Time Frame: In 2 weeks
|
In 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
July 28, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2010
Last Update Submitted That Met QC Criteria
February 25, 2010
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCS-09-266
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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