BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

NCT05683821 | Completed DMC

• 5 other identifiers: 2022-09732P01CA180945-06A534253SMPH/MEDICINE/GEN INT MDProtocol Version 07/11/2022
• Study Type: interventional
• Target: 12,376
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.

Conditions

Quitting Smoking; Smoking Cessation; Smoking, Cigarette

Outcome Measures

Primary Outcomes (1)

• Smoking treatment initiation within 12 months of enrollment

  The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.

  Up to 12 months

Secondary Outcomes (4)

• Smoking treatment initiation within 18 months of enrollment

  Up to 18 months

• Conversion from current smoking to former smoking

  12 and 18 months after study enrollment

• Cost per quit attempt

  Up to 18 months

• Cost per quit

  Up to 18 months

Study Arms (2)

Enhanced outreach

EXPERIMENTAL

Quarterly outreach via letter and applicable patient-preferred modalities, including e-mail and/or text messaging, offering both standard person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and self-guided, remote treatment options (mailed nicotine replacement therapy samples and/or facilitated enrollment in a Smokefree.gov texting program). Patients in clinics assigned to this arm will also have the option to initiate treatment by phone or online. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.

Behavioral: Text message smoking treatment; Drug: Nicotine replacement therapy sampling; Combination Product: Wisconsin Tobacco QuitLine Referral; Combination Product: Referral to Primary Care Provider; Combination Product: BREATHE 2 Cessation Study; Behavioral: Additional modalities to learn about and request treatment

Standard outreach

ACTIVE COMPARATOR

One mailed letter at study initiation outlining available person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and how to initiate treatment by phone. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.

Combination Product: Wisconsin Tobacco QuitLine Referral; Combination Product: Referral to Primary Care Provider; Combination Product: BREATHE 2 Cessation Study

Interventions

Text message smoking treatment BEHAVIORAL

Facilitated enrollment in an NCI-sponsored text messaging program: * SmokefreeTXT (if ready to set a quit date in the next 14 days) * Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently) * Daily Challenges (if not ready to quit, but willing to make some changes)

Enhanced outreach

Nicotine replacement therapy sampling DRUG

Participants may request: * Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses * Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses

Also known as: Nicoderm, Nicorette

Enhanced outreach

Wisconsin Tobacco QuitLine Referral COMBINATION_PRODUCT

Patients will be offered referral to the Wisconsin Tobacco QuitLine that offers phone counseling and nicotine replacement starter kits (2 week supplies) to people ready to quit smoking, in addition to web-based, text messaging, and mailed support, at no cost to Wisconsin residents.

Enhanced outreach; Standard outreach

Referral to Primary Care Provider COMBINATION_PRODUCT

Patients who want to talk to their Primary Care Providers about quitting smoking will be encouraged to make an appointment with their provider to receive smoking cessation counseling and to discuss pharmacotherapy options.

Enhanced outreach; Standard outreach

BREATHE 2 Cessation Study COMBINATION_PRODUCT

Patients who are interested in participating in a separate randomized controlled trial of smoking cessation treatment will be invited to learn about and complete an eligibility screening and consent process for the trial. Those who enter the study receive both counseling and pharmacotherapy.

Enhanced outreach; Standard outreach

Additional modalities to learn about and request treatment BEHAVIORAL

Participants in Enhanced Outreach arm clinics will have the option to request e-mail and/or text message communication regarding their smoking treatment options, and to initiate treatment via phone or online survey.

Enhanced outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age 18 years or older
• Being seen in a participating clinic in the past 1-3 years, as documented in the EHR
• Having a valid address
• Not having a language other than English listed as preferred language

You may not qualify if:

• Invalid address
• Participant opted out of the study within 18 months of initial outreach letter (or were opted out of the study by a legally authorized representative or an activated power of attorney for health care)
• Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking

Interventions

Nicotine; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Danielle E McCarthy, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized controlled

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: July 24, 2023
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)