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Trial record 77 of 661 for:    applied AND web-

Smartphone Mobile Applications in Enhancing Smoking Cessation Treatment in Current Smokers

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ClinicalTrials.gov Identifier: NCT03519451
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 31, 2019
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
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.


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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, 2019
Estimated Study Completion Date : December 31, 2019

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

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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
  • Current smoker (i.e., at least 5 cigarettes/day)
  • Smoking for at least one year
  • Carbon monoxide (CO) level of 5 ppm or greater, confirming smoking status
  • Willing to set a quit date in the next 30 days
  • Not engaged in smoking cessation treatment other than the MD Anderson Cancer Center (MDACC) Tobacco Treatment Program
  • Currently elevated depressive symptoms; (Patient Health Questionnaire [PHQ] 2 = or > 1); current or past
  • English speaking and ability to read and comprehend English
  • Currently own an iOS mobile phone (iPhone) 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
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Contact: Jennifer Minnix 713-792-0476 jminnix@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer A. Minnix    713-792-0476      
Principal Investigator: Jennifer A. Minnix         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer A Minnix M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03519451     History of Changes
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: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No