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

Primary Purpose

Depression, Tobacco Use Disorder, Current Every Day Smoker

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Internet-Based Intervention
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (KickAsh smartphone mobile application)

Group II (Breathe2Relax smartphone mobile application)

Arm Description

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

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

Outcomes

Primary Outcome Measures

KickAsh group compliance with mood rating
KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.
KickAsh group change in activity level
KickAsh group change in activity level determined by questionnaires, phone calls, and interview.
KickAsh group user satisfaction
KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.
Evidence of increased activity level in KickAsh and Breathe2Relax groups
Increase in activity level determined by questionnaires, phone calls, and interview.
Evidence of improved mood in KickAsh and Breathe2Relax groups
Evidence of improved mood determined by questionnaires, phone calls, and interview.
Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups
Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2018
Last Updated
September 14, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03519451
Brief Title
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
Official Title
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Tobacco Use Disorder, Current Every Day Smoker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (KickAsh smartphone mobile application)
Arm Type
Experimental
Arm Description
Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.
Arm Title
Group II (Breathe2Relax smartphone mobile application)
Arm Type
Experimental
Arm Description
Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Given KickAsh smartphone mobile application
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Given Breathe2Relax smartphone mobile application
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
KickAsh group compliance with mood rating
Description
KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study
Title
KickAsh group change in activity level
Description
KickAsh group change in activity level determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study
Title
KickAsh group user satisfaction
Description
KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study
Title
Evidence of increased activity level in KickAsh and Breathe2Relax groups
Description
Increase in activity level determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study
Title
Evidence of improved mood in KickAsh and Breathe2Relax groups
Description
Evidence of improved mood determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study
Title
Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups
Description
Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.
Time Frame
Up to 8 weeks from start of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Minnix
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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