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Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

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ClinicalTrials.gov Identifier: NCT02973425
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rajani Sadasivam, University of Massachusetts, Worcester

Brief Summary:
Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase Behavioral: NRT and mHealth assessment tool without feedback Not Applicable

Detailed Description:

The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are

  • AIM 1: Refine the Take a Break mHealth tool and implementation program.
  • AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.
  • AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NRT and mHealth assessment tool without feedback

For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control.

Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the "Challenge Quizzes" but without feedback.

Behavioral: NRT and mHealth assessment tool without feedback
NRT and mHealth assessment tool without feedback

Experimental: Take a Break as an augmentation to NRT in Motivation
The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the "Break," is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the "Marathon", our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite.
Behavioral: Take a Break as an augmentation to NRT-sampling in Motivation Phase
NRT sampling experience & Suite of mHealth motivational tools and mini-games.




Primary Outcome Measures :
  1. Lower time to first quit attempt (1-survival in longitudinal analysis) Time to first quit attempt (mean survival) [ Time Frame: 6 months ]
    Quit attempts and cessation will be assessed at follow-up surveys at 6 months. Quit attempts will be assessed using the Timeline follow back method, which uses a calendar to reconstruct smoking behaviors


Secondary Outcome Measures :
  1. Greater increase in self-efficacy at the end of the 3-week experience: [ Time Frame: 3 week ]
    Change in Self-Efficacy is defined as the difference in reported self-efficacy (SEQ-12)28 comparing baseline and follow-up at the end of the 3 week experience for intervention and NRT-only comparison patients

  2. Higher rate of point prevalent cessation measured at 6 months Six-month point prevalent smoking cessation [ Time Frame: 6 months ]
    Smoking cessation trialists have recommended assessment of smoking cessation in randomized trials of motivational interventions of point prevalence cessation. The Take a Break trial is defined as a test of treatment to motivation cessation (also termed cessation induction). As Hughes and colleagues for the Society for Research in Nicotine and Tobacco Workgroup on Measurement note, point prevalence cessation is often the best measure for motivation phase trials.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.

Exclusion Criteria:

  • Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.

Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973425


Locations
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United States, Massachusetts
Reliant Medical Group
Worcester, Massachusetts, United States, 01605
VA Central Western Massachusetts Healthcare System
Worcester, Massachusetts, United States, 01605
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, New York
Northwell Health
Great Neck, New York, United States, 11030
Sponsors and Collaborators
University of Massachusetts, Worcester
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rajani S Sadasivam, PhD UMMS
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Responsible Party: Rajani Sadasivam, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02973425    
Other Study ID Numbers: H00007427
R01CA190866-01A1 ( U.S. NIH Grant/Contract )
R25CA172009-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajani Sadasivam, University of Massachusetts, Worcester:
mHealth, Smoking cessation,