The Positively Quit Trial for Smoking Cessation

NCT04449458 | Recruiting DMC

• 2 other identifiers: Pro00040192R01CA243800
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered via videoconferencing groups works better than a control condition--a program that is not designed to help with smoking but that does have the same number of group contact hours as the other program (this program is called the Attention Matched Control condition; AMC) for helping people with certain health conditions stop smoking. People in both groups will receive brief advice to quit and an offer of nicotine replacement therapy patches (NRT), as well as 12 videoconferencing group sessions. The team will measure smoking behavior over a one-year period and compare smoking rates for the treatment condition against AMC to see if the treatment condition is better at getting people living with certain health conditions to quit smoking.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (3)

• Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360

  Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  study day 360

• Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360

  Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  study day 360

• Biochemically confirmed sustained abstinence (BC.SA) day 360

  At day 42 (2 weeks post-quit day; provides a grace period), participant is asked the BC7ppa question (see outcome 1). Then, at each full and brief assessment going forward, beginning at day 90, participant is asked if she has smoked a cigarette, even a puff, since the last assessment. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC.SA will be coded as abstinence-indicating if she answers "no" to the sustained abstinence question at each assessment and cotinine levels at each assessment suggest abstinence.

  Study day 360

Secondary Outcomes (8)

• Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 42

  study day 42

• Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 90

  study day 90

• Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 180

  study day 180

• Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) days 90

  study day 90

• Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 180

  study day 180

Study Arms (2)

Positively Me

EXPERIMENTAL

Positively Me is a 12-session (8 \[1.5\] hour main sessions plus four booster sessions) intervention guided by Social Cognitive Theory to promote smoking cessation in people with certain health conditions.

Behavioral: Positively Me

Positively Living

SHAM COMPARATOR

Positively Living is a modified updated version of a healthy living intervention based on Social Cognitive Theory that is designed for people with certain health conditions and attention-matched to the experimental condition (8 \[1.5\] hour main sessions plus four booster sessions).

Behavioral: Positively Living

Interventions

Positively Me BEHAVIORAL

12 session smoking cessation intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Also known as: Positively Smoke Free-Video Group

Positively Me

Positively Living BEHAVIORAL

12 session healthy living intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Positively Living

Eligibility Criteria

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

You may qualify if:

• greater than or equal to age 18 (as NRT is not FDA approved for adolescents)
• self-report smoking cigarettes
• positive cotinine test
• motivated to quit
• own a smart phone, laptop, desktop, or tablet computer
• able to join group from a private space with Internet access
• demonstrate the ability to connect to the HIPAA-compliant videoconferencing system, Zoom, over the internet h) speak English i) living in the US j) living with certain health conditions

You may not qualify if:

• pregnant, breastfeeding, or have other contraindications to NRT
• receiving other tobacco treatment, or
• inability to communicate coherently in English during the video-conferencing test or other pre-enrollment interactions

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of South Florida, College of Nursing

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Stephanie L Marhefka, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catheryn Flores, MPH

CONTACT

813-396-2014; catherynf@usf.edu

Shanna Hunt

CONTACT

sphunt@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Associate Dean of Research

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: June 10, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 months of article publication, quantitative data will be available to those requesting it who meet access criteria
• Access Criteria: Requests for data should be made to the PI. Requesters must provide evidence of training in the protection of human subjects in research, and demonstrate approval from their institutional review board for the analyses, noting what procedures will take place to protect the data. Requesters will also be asked to sign a confidentiality agreement noting personal measures to ensure privacy of data.

Locations

US (1)