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Trial of An Innovative Smartphone Intervention for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02724462
Recruitment Status : Completed
First Posted : March 31, 2016
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
University of Washington
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE March 31, 2016
Results First Submitted Date  ICMJE November 12, 2020
Results First Posted Date  ICMJE January 5, 2021
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE May 27, 2017
Actual Primary Completion Date December 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
30-day Point Prevalence Abstinence, Complete-case [ Time Frame: 12 months post randomization ]
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
30-day point prevalence abstinence [ Time Frame: 12 months post randomization ]
No smoking in the past 30 days, as reported 12 month post treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
30-day Point Prevalence Abstinence, Missing=Smoking Imputation [ Time Frame: 12 months post randomization ]
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of An Innovative Smartphone Intervention for Smoking Cessation
Official Title  ICMJE Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation
Brief Summary The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE
  • Behavioral: Smartphone-delivered Intervention (SmartQuit)
    The experimental arm includes an intervention using a novel smartphone smoking cessation app.
  • Behavioral: : Smartphone-delivered Intervention (Standard of care app)
    The control intervention uses a standard of care smartphone smoking cessation app.
Study Arms  ICMJE
  • Experimental: Experimental
    This is the experimental arm of the study. This includes receiving the novel/experimental smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study.
    Intervention: Behavioral: Smartphone-delivered Intervention (SmartQuit)
  • Active Comparator: Control
    This is the control arm of the study. This includes receiving the standard of care smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study.
    Intervention: Behavioral: : Smartphone-delivered Intervention (Standard of care app)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2018)
2503
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
1622
Actual Study Completion Date  ICMJE December 27, 2019
Actual Primary Completion Date December 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 or older
  • smokes at least five cigarettes daily for at least past 12 months
  • wants to quit cigarette smoking in the next 30 days
  • if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
  • interested in learning skills to quit smoking
  • willing to be randomly assigned to either condition
  • resides in US
  • has at least daily access to their own personal Apple iPhone, Android, or Windows Phone
  • knows how to login and download a smartphone application
  • willing and able to read in English
  • not using other smoking cessation interventions (including apps or our other intervention studies).
  • willing to complete all three follow-up surveys
  • provide email, phone, and mailing address.

Exclusion Criteria:

  • The exclusion criteria are opposite of the inclusion criteria listed above.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02724462
Other Study ID Numbers  ICMJE 8317
NCI-2018-02662 ( Registry Identifier: NCI / CTRP )
RG1001191 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
R01CA192849 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • University of Washington
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jonathan Bricker, Ph.D. Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP