Tobacco AbusePhase 3NCT01575119
Decision Aid for Cigarette Smokers Undergoing Surgery
A Phase 3 study testing Decision Aid in people with Tobacco Abuse, run by Mayo Clinic at 1 site in United States.
Trial summary
Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Abuse
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2014
- Phase
- Phase 3
- 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
- Scheduled to undergo elective surgery at Mayo Clinic Rochester
- Age 18 years or older
- Able to fully participate in all study aspects
Who cannot join
- Unavailable for telephone follow-up
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 2
Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. This second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.
- Conditions
- Tobacco Abuse
- Being tested
- Decision Aid, Control intervention, Control
- Keywords
- Cigarette smoker, Elective surgery
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
Control interventionBehavioural
Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking
Decision AidBehavioural
Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
ControlBehavioural
Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
| Study group | Role | What they receive |
|---|---|---|
| In-patient surgery | Experimental | Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery Receives: Behavioral: Decision Aid |
| In-patient | Active comparator | Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking Receives: Behavioral: Control intervention |
| Out-patient surgery | Experimental | Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery Receives: Behavioral: Decision Aid |
| Out-patient | Active comparator | Standard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of decisional quality
The Decisional Conflict Scale and the OPTION Scale will be utilized
Measured: Assessed immediately after the time of the preoperative conversation in the preoperative clinic
Secondary outcomes (1)
Measures of intent and self-efficacy
Intent to quit smoking, and self-efficacy for quitting
Measured: Immediately after the preoperative evaluation in the preoperative clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco AbuseStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Warner, Mayo Clinic
- Investigators
- David Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575119
- Sponsor's protocol ID
- 11-009150
- Status last verified
- Dec 2014
- First submitted
- 5 Apr 2012
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. 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 2
- ClinicalTrials.gov ID
- NCT01575119
- Acronym / sponsor ID
- 11-009150
- Conditions
- Tobacco Abuse
- Keywords
- Cigarette smoker, Elective surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Apr 2012 (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.
Smokers have three choices when faced with surgery: keep smoking, quit for a short time around surgery or quit for good. In the first specific aim, a decision aid was designed to help facilitate the discussion of these choices between smokers and healthcare providers. This second aim will test whether this decision aid improves the decisional quality compared with standard methods used to discuss perioperative smoking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In-patient surgery | Experimental | Behavioral: Decision AidDecision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery |
| In-patient | Active comparator | Behavioral: Control interventionStandard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking |
| Out-patient surgery | Experimental | Behavioral: Decision AidDecision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery |
| Out-patient | Active comparator | Behavioral: ControlStandard of care information, including distributing a patient education brochure, to provide information regarding perioperative smoking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current cigarette smoker
- Scheduled to undergo elective surgery at Mayo Clinic Rochester
- Age 18 years or older
- Able to fully participate in all study aspects
Key exclusion criteria (1 listed)
- Unavailable for telephone follow-up
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 tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery | Behavioural | In-patient surgery |
| Control interventionStandard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking | Behavioural | In-patient |
| Decision AidDecision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery | Behavioural | Out-patient surgery |
| ControlStandard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking | Behavioural | Out-patient |
Primary outcome
Measures of decisional quality
Time frame: Assessed immediately after the time of the preoperative conversation in the preoperative clinic
The Decisional Conflict Scale and the OPTION Scale will be utilized
1 secondary outcome
Measures of intent and self-efficacy
Time frame: Immediately after the preoperative evaluation in the preoperative clinic
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 17 Dec 2014.
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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 3 study testing Decision Aid in people with Tobacco Abuse, 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 4 inclusion and 1 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 17 Dec 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Measures of decisional quality (time frame: Assessed immediately after the time of the preoperative conversation in the preoperative clinic). 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 17 Dec 2014.