Stomach CancerPhase 2NCT00948337
A Study With Health Educational Material on Health Promotion in Cancer Survivors
A Phase 2 study testing Brochure of Secondary Cancer Screening in people with Stomach Cancer and Colon Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Cancer, Colon Cancer, Thyroid Cancer
- What is being tested?
- Brochure of Secondary Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ECOG 3,4
- Disagree with the investigators study purpose
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Samsung Medical Center
Seoul, 135-710
About this study
Official title: 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.
- Conditions
- Stomach Cancer, Colon Cancer, Thyroid Cancer, Breast Cancer
- Being tested
- Brochure of Secondary Cancer Screening
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Thyroid Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure of Secondary Cancer ScreeningBehavioural
One kind of printed educational material
| Study group | Role | What they receive |
|---|---|---|
| Photonovella of Secondary Cancer Screening | Experimental | Not described Receives: Behavioral: Brochure of Secondary Cancer Screening |
| Photonovella of Dietary Suppelment of Cancer survivor | Active comparator | Not described Receives: Behavioral: Brochure of Secondary Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening behavior for second primary cancer
Measured: After 1 yr
Secondary outcomes (1)
Knowledge and attitudes of Secondary cancer screening and dietary supplement
Measured: In 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948337
- Sponsor's protocol ID
- NCS-09-266
- Status last verified
- Sep 2009
- First submitted
- 28 Jul 2009
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22479375
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Intervention With Health Educational Material on Knowledge, Attitude, and Behavior in Cancer Survivors
- ClinicalTrials.gov ID
- NCT00948337
- Acronym / sponsor ID
- NCS-09-266
- Conditions
- Stomach Cancer, Colon Cancer, Thyroid Cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 29 Jul 2009 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photonovella of Secondary Cancer Screening | Experimental | Behavioral: Brochure of Secondary Cancer Screening |
| Photonovella of Dietary Suppelment of Cancer survivor | Active comparator | Behavioral: Brochure of Secondary Cancer Screening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- ECOG 3,4
- Disagree with the investigators study purpose
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 |
|---|---|---|
| Brochure of Secondary Cancer ScreeningOne kind of printed educational material | Behavioural | Photonovella of Dietary Suppelment of Cancer survivor, Photonovella of Secondary Cancer Screening |
Primary outcome
Screening behavior for second primary cancer
Time frame: After 1 yr
1 secondary outcome
Knowledge and attitudes of Secondary cancer screening and dietary supplement
Time frame: In 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Derived from this study: PubMed 22479375Shin 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brochure of Secondary Cancer Screening in people with Stomach Cancer and Colon Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Screening behavior for second primary cancer (time frame: After 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948337, which also lists 1 linked publication.
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 26 Feb 2010.