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A Study With Health Educational Material on Health Promotion in Cancer Survivors

Primary Purpose

Stomach Cancer, Colon Cancer, Thyroid Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Brochure of Secondary Cancer Screening
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomach Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photonovella of Secondary Cancer Screening

Photonovella of Dietary Suppelment of Cancer survivor

Arm Description

Outcomes

Primary Outcome Measures

Screening behavior for second primary cancer

Secondary Outcome Measures

Knowledge and attitudes of Secondary cancer screening and dietary supplement

Full Information

First Posted
July 28, 2009
Last Updated
February 25, 2010
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00948337
Brief Title
A Study With Health Educational Material on Health Promotion in Cancer Survivors
Official Title
A Randomized Controlled Trial on the Effect of Intervention With Health Educational Material on Knowledge, Attitude, and Behavior in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer, Colon Cancer, Thyroid Cancer, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photonovella of Secondary Cancer Screening
Arm Type
Experimental
Arm Title
Photonovella of Dietary Suppelment of Cancer survivor
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brochure of Secondary Cancer Screening
Intervention Description
One kind of printed educational material
Primary Outcome Measure Information:
Title
Screening behavior for second primary cancer
Time Frame
After 1 yr
Secondary Outcome Measure Information:
Title
Knowledge and attitudes of Secondary cancer screening and dietary supplement
Time Frame
In 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22479375
Citation
Shin DW, Cho J, Kim YW, Oh JH, Kim SW, Chung KW, Lee WY, Lee JE, Guallar E, Lee WC. Efficacy of an educational material on second primary cancer screening practice for cancer survivors: a randomized controlled trial. PLoS One. 2012;7(3):e33238. doi: 10.1371/journal.pone.0033238. Epub 2012 Mar 29.
Results Reference
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A Study With Health Educational Material on Health Promotion in Cancer Survivors

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