Oral CancerNCT01351532
Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention
A study testing smoking cessation program and Lifestyle counseling in people with Oral Cancer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Oral Cancer
- What is being tested?
- smoking cessation program and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Dec 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of oral cancer
- current smoker
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.
- Conditions
- Oral Cancer
- Being tested
- smoking cessation program, Lifestyle counseling
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation programBehavioural
cross-theoretical model integrating smoking cessation counseling, smoking cessation drug utilization, physician interview and telephone counseling persuasion,
Lifestyle counselingBehavioural
ross-theoretical model integrating smoking cessation counseling,physician interview and telephone counseling persuasion
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling, smoking cessation drug | Experimental | Not described Receives: Behavioral: smoking cessation program |
| Lifestyle counseling | Active comparator | Not described Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
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 May 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351532
- Sponsor's protocol ID
- DMR100-IRB-063
- Status last verified
- Jan 2012
- First submitted
- 9 May 2011
- Last updated
- 1 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention
- ClinicalTrials.gov ID
- NCT01351532
- Acronym / sponsor ID
- DMR100-IRB-063
- Conditions
- Oral Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 May 2011 (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 research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling, smoking cessation drug | Experimental | Behavioral: smoking cessation program |
| Lifestyle counseling | Active comparator | Behavioral: Lifestyle counseling |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of oral cancer
- current smoker
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| smoking cessation programcross-theoretical model integrating smoking cessation counseling, smoking cessation drug utilization, physician interview and telephone counseling persuasion, | Behavioural | Lifestyle counseling, smoking cessation drug |
| Lifestyle counselingross-theoretical model integrating smoking cessation counseling,physician interview and telephone counseling persuasion | Behavioural | Lifestyle counseling |
Primary outcome
Smoking cessation
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 1 Feb 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation program and Lifestyle counseling in people with Oral Cancer, run by China Medical University Hospital at 1 site in Taiwan.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 1 Feb 2012. 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 Taiwan. 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?
Smoking cessation (time frame: 6 months). 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 1 Feb 2012.