Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519451
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.

Condition or disease Intervention/treatment Phase
Depression Tobacco Use Disorder Current Every Day Smoker Other: Internet-Based Intervention Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To test the acceptability and preliminary efficacy of a smartphone health application (app), Kick Ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

GROUP II: Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (KickAsh smartphone mobile application)
Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.
Other: Internet-Based Intervention
Given KickAsh smartphone mobile application

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (Breathe2Relax smartphone mobile application)
Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.
Other: Internet-Based Intervention
Given Breathe2Relax smartphone mobile application

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. KickAsh group compliance with mood rating [ Time Frame: Up to 8 weeks from start of study ]
    KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.

  2. KickAsh group change in activity level [ Time Frame: Up to 8 weeks from start of study ]
    KickAsh group change in activity level determined by questionnaires, phone calls, and interview.

  3. KickAsh group user satisfaction [ Time Frame: Up to 8 weeks from start of study ]
    KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.

  4. Evidence of increased activity level in KickAsh and Breathe2Relax groups [ Time Frame: Up to 8 weeks from start of study ]
    Increase in activity level determined by questionnaires, phone calls, and interview.

  5. Evidence of improved mood in KickAsh and Breathe2Relax groups [ Time Frame: Up to 8 weeks from start of study ]
    Evidence of improved mood determined by questionnaires, phone calls, and interview.

  6. Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups [ Time Frame: Up to 8 weeks from start of study ]
    Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • MD Anderson patient between the ages of 18 to 65
  • Current smoker (i.e., at least 1 cigarette or e-cigarette per day)
  • Smoking for at least one year
  • Willing to set a quit date in the next 30 days
  • Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
  • Currently elevated depressive symptoms or a history of elevated depressive symptoms; (PHQ 2 = or > 1); current or past
  • English speaking and ability to read and comprehend English
  • Currently own an iOS mobile phone or tablet (iPhone; iPad) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app

Exclusion Criteria:

  • Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator
  • Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of 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): NCT03519451


Contacts
Layout table for location contacts
Contact: Jennifer Minnix 713-792-0476 jminnix@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer A. Minnix    713-792-0476    jminnix@mdanderson.org   
Principal Investigator: Jennifer A. Minnix         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer A Minnix M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03519451    
Other Study ID Numbers: 2017-0720
NCI-2018-01158 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0720 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R43CA206682 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders