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

NCT03519451 | Active Not Recruiting FDA Device

• 3 other identifiers: 2017-0720NCI-2018-01158R43CA206682
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Tobacco Use Disorder; Current Every Day Smoker

Outcome Measures

Primary Outcomes (6)

• KickAsh group compliance with mood rating

  KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.

  Up to 8 weeks from start of study

• KickAsh group change in activity level

  KickAsh group change in activity level determined by questionnaires, phone calls, and interview.

  Up to 8 weeks from start of study

• KickAsh group user satisfaction

  KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.

  Up to 8 weeks from start of study

• Evidence of increased activity level in KickAsh and Breathe2Relax groups

  Increase in activity level determined by questionnaires, phone calls, and interview.

  Up to 8 weeks from start of study

• Evidence of improved mood in KickAsh and Breathe2Relax groups

  Evidence of improved mood determined by questionnaires, phone calls, and interview.

  Up to 8 weeks from start of study

• Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups

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

  Up to 8 weeks from start of study

Study Arms (2)

Group I (KickAsh smartphone mobile application)

EXPERIMENTAL

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

Other: Internet-Based Intervention; Other: Questionnaire Administration

Group II (Breathe2Relax smartphone mobile application)

EXPERIMENTAL

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

Other: Internet-Based Intervention; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Given KickAsh smartphone mobile application

Group I (KickAsh smartphone mobile application)

Questionnaire Administration OTHER

Ancillary studies

Group I (KickAsh smartphone mobile application); Group II (Breathe2Relax smartphone mobile application)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Depression; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jennifer A Minnix

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: April 25, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)