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Trial of An Innovative Smartphone Intervention for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Smartphone-delivered Intervention (SmartQuit) Behavioral: : Smartphone-delivered Intervention (Standard of care app) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation
Actual Study Start Date : May 27, 2017
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Smartphone-delivered Intervention (SmartQuit)
The experimental arm includes an intervention using a novel smartphone smoking cessation app.
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.
 Behavioral: : Smartphone-delivered Intervention (Standard of care app)
The control intervention uses a standard of care smartphone smoking cessation app.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT02724462


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Center
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jonathan Bricker, Ph.D. Fred Hutchinson Cancer Center
  Study Documents (Full-Text)

Documents provided by Fred Hutchinson Cancer Center:
Informed Consent Form  [PDF] October 18, 2018
Study Protocol and Statistical Analysis Plan  [PDF] October 5, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT02724462    
Other Study ID Numbers: 8317
NCI-2018-02662 ( Registry Identifier: NCI / CTRP )
RG1001191 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
R01CA192849 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2016    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
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 Fred Hutchinson Cancer Center:
smoking cessation
app for quitting smoking