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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03519451
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 68.2
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Tobacco Use Disorder; Current Every Day Smoker	Other: Internet-Based Intervention; Other: Internet-Based Intervention; Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 25, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. KickAsh group compliance with mood rating [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 [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 [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 [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 [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 [Up to 8 weeks from start of study]

   Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer A Minnix, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT03519451
• Other Study ID Numbers: 2017-0720; NCI-2018-01158; 2017-0720; R43CA206682
• First Posted: May 9, 2018
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

No Results Posted as of Feb 28, 2022