- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839043
Short Messaging Service Program to Help Quit Smoking During Perioperative Period. (SMS2QUIT)
July 8, 2021 updated by: David Warner, Mayo Clinic
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Surgery on the day of POE evaluation
- Any active psychiatric condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Quit for a bit"
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.
|
"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.
"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.
|
|
Active Comparator: "Quit for good"
Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program.
|
"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.
"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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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
|
Cumulative from Day 1 to Day 30 Post Op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David O Warner, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2019
Primary Completion (Actual)
June 11, 2021
Study Completion (Actual)
June 11, 2021
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 11, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-010950
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Smoking
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Johns Hopkins UniversityNational Center for Advancing Translational Sciences (NCATS); Community Partnership...CompletedSmoking Cessation | Smoking Reduction | Smoking, TobaccoUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
University of Colorado, DenverUniversity of OklahomaRecruitingSmoking Cessation | Tobacco | Quitting Smoking | Tobacco Abstinence | Smoking (Tobacco) Addiction | Smoking ( Cigarette)United States
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedTobacco Smoking | Cigarette Smoking | Smoking, TobaccoUnited States
-
University of ArizonaNational Center for Complementary and Integrative Health (NCCIH); West Virginia...CompletedSmoking Cessation | Tobacco Use | Tobacco Smoking | Smoking, Tobacco | Guided ImageryUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Completed
-
RAI Services CompanyNot yet recruitingSmoking | TobaccoUnited States
-
RAI Services CompanyTerminatedSmoking | TobaccoUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States
Clinical Trials on Brief behavioral intervention
-
University of Mississippi Medical CenterTerminatedDepression | Asthma | UrticariaUnited States
-
Hospital General de MexicoEnrolling by invitationDepression | Anxiety | Sleep Quality | Insomnia Chronic | Life QualityMexico
-
University of PittsburghNational Institute of Mental Health (NIMH)RecruitingSleep | Sleep Disturbance | Attention Deficit and Disruptive Behavior Disorders | Attention Deficit Hyperactivity Disorder | Child, PreschoolUnited States
-
The Miriam HospitalNational Institute of Mental Health (NIMH); University of Rochester; Syracuse...CompletedHIV Infections | Sexually Transmitted DiseasesUnited States
-
Universidad Santo Tomas, ChileUniversidad de ConcepcionCompletedDepressive Symptoms | Posttraumatic Stress Disorder | Acute Post-Traumatic Stress DisorderChile
-
HBSAAB InBev FoundationRecruitingAlcohol Use DisorderSouth Africa, Mexico
-
University of MinnesotaCompleted
-
Universidad Nacional Autonoma de HondurasUnknownAnxiety | Depressive Symptoms | Perceived Stress | Post Traumatic Stress SymptomsHonduras
-
St. Olavs HospitalNorwegian University of Science and Technology; The Research Council of Norway and other collaboratorsActive, not recruitingSexual Dysfunctions, Psychological | Sleep Disturbance | Post Traumatic Stress Disorder | Depression, Anxiety | Activity, Motor | Pelvic Pain Syndrome | Rape Sexual Assault | Pelvic Floor Myalgia | Cortisol DeficiencyNorway
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); California... and other collaboratorsCompletedInsulin Sensitivity | Obesity, AbdominalUnited States