SmokingPhase 1NCT01193972
Decision Aid Development for Smokers
A Phase 1 study testing Decision aid in people with Smoking and Elective Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
A decision aid tool will be developed using participatory research approach. The decision aid will be targeted to cigarette smokers scheduled for elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Elective Surgery
- What is being tested?
- Decision aid
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current cigarette smoker having elective surgery at Mayo Clinic Rochester and is scheduled to be seen at Preoperative Evaluation Center.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 1
A decision aid tool will be developed using participatory research approach. The decision aid will be targeted to cigarette smokers scheduled for elective surgery.
- Conditions
- Smoking, Elective Surgery
- Being tested
- Decision aid
- Keywords
- Smoking cessation, Smoking, Tobacco
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
Decision aid to assist patients in making a decision about smoking during the perioperative period
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Decisional Conflict Scale and COMRADE Scale
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- David Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193972
- Sponsor's protocol ID
- 10-005126
- Status last verified
- Feb 2013
- First submitted
- 31 Aug 2010
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid Development for Cigarette Smokers Undergoing Surgery: Specific Aim 1
- ClinicalTrials.gov ID
- NCT01193972
- Acronym / sponsor ID
- 10-005126
- Conditions
- Smoking, Elective Surgery
- Keywords
- Smoking cessation, Smoking, Tobacco
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Sep 2010 (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.
A decision aid tool will be developed using participatory research approach. The decision aid will be targeted to cigarette smokers scheduled for elective surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current cigarette smoker having elective surgery at Mayo Clinic Rochester and is scheduled to be seen at Preoperative Evaluation Center.
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 |
|---|---|---|
| Decision aidDecision aid to assist patients in making a decision about smoking during the perioperative period | Other | – |
Primary outcome
Score on Decisional Conflict Scale and COMRADE Scale
Time frame: Perioperative period
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 27 Feb 2013.
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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.
David Warner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decision aid in people with Smoking and Elective Surgery, run by Mayo Clinic 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?
The sponsor lists 1 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 27 Feb 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Score on Decisional Conflict Scale and COMRADE Scale (time frame: Perioperative period). 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 27 Feb 2013.