Tobacco Use CessationSMS2QUITNCT03839043
Short Messaging Service Program to Help Quit Smoking During Perioperative Period.
A study testing Brief behavioral intervention and SMS Program in people with Tobacco Use Cessation and Perioperative/Postoperative Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Perioperative/Postoperative Complications, Tobacco Smoking
- What is being tested?
- Brief behavioral intervention and SMS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 11 Jun 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment
- Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and;
- Owning a device with access to SMS with an unlimited text plan
Who cannot join
- Surgery on the day of POE evaluation
- Any active psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.
Read the detailed description
The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery ("quit for a bit") can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence ("quit for good").
- Being tested
- Brief behavioral intervention, SMS Program
- Keywords
- Tobacco, Cigarettes, Surgery, Text Message, SMS
- Medical subject headings
- Tobacco Use Cessation, Postoperative Complications, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief behavioral interventionBehavioural
"Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.
SMS ProgramOther
"Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| "Quit for a bit" | Experimental | Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program. Receives: Behavioral: Brief behavioral intervention; Other: SMS Program |
| "Quit for good" | Active comparator | Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program. Receives: Behavioral: Brief behavioral intervention; Other: SMS Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.
Measured: 30 days Post Op
The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects
Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service
Measured: Cumulative from Day 1 to Day 30 Post Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Mar 2019
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
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 Tobacco Use CessationStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a "quit for a bit" or a "quit for good" intervention. Both stratums employ a Short Message Service (SMS or "text") to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The "quit for a bit" intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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 O Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839043
- Sponsor's protocol ID
- 18-010950
- Acronym
- SMS2QUIT
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jose T, Cha S, Graham AL, Amato MS, Schroeder DR, Warner DO. Effect of Messaging Content on Engagement With a Short Messaging Service for Perioperative Smoking Cessation. Nicotine Tob Res. 2023 Jul 14;25(8):1465-1473. doi: 10.1093/ntr/ntad061.
PubMed 37058426
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.
- ClinicalTrials.gov ID
- NCT03839043
- Acronym / sponsor ID
- SMS2QUIT / 18-010950
- Keywords
- Tobacco, Cigarettes, Surgery, Text Message, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.
Detailed description
The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery ("quit for a bit") can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence ("quit for good").
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a "quit for a bit" or a "quit for good" intervention. Both stratums employ a Short Message Service (SMS or "text") to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The "quit for a bit" intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
| Arm | Type | Receives |
|---|---|---|
| "Quit for a bit" | Experimental | Behavioral: Brief behavioral intervention, Other: SMS ProgramBrief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program. |
| "Quit for good" | Active comparator | Behavioral: Brief behavioral intervention, Other: SMS ProgramBrief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment
- Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and;
- Owning a device with access to SMS with an unlimited text plan
Key exclusion criteria (2 listed)
- Surgery on the day of POE evaluation
- Any active psychiatric condition
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 |
|---|---|---|
| Brief behavioral intervention"Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure. | Behavioural | "Quit for a bit", "Quit for good" |
| SMS Program"Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes. | Other | "Quit for a bit", "Quit for good" |
Primary outcome
Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
Time frame: 30 days Post Op
Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.
The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects
Time frame: Cumulative from Day 1 to Day 30 Post Op
Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service
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 9 Jul 2021.
- Derived from this study: PubMed 37058426Jose T, Cha S, Graham AL, Amato MS, Schroeder DR, Warner DO. Effect of Messaging Content on Engagement With a Short Messaging Service for Perioperative Smoking Cessation. Nicotine Tob Res. 2023 Jul 14;25(8):1465-1473. doi: 10.1093/ntr/ntad061.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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 O 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 study testing Brief behavioral intervention and SMS Program in people with Tobacco Use Cessation and Perioperative/Postoperative Complications, 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 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: finished, as of the sponsor's last update on 9 Jul 2021. 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.
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?
Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30 (time frame: 30 days Post Op). The study lists 2 primary outcomes in all. 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 NCT03839043, 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 9 Jul 2021.