Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

NCT05038852 | Active Not Recruiting

• 2 other identifiers: 2018-0984NCI-2021-09413
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.

Conditions

Smoking Cessation; Tobacco

Outcome Measures

Primary Outcomes (1)

• To assess the adherence of a smartphone mobile health app.

  through study completion, an average of 1 year

Study Arms (2)

Group 1 smartphone applications

OTHER

app is designed to help you learn relaxation skills

Device: smartphone applications

Group 2 smartphone applications

OTHER

app is designed to help you increase your positive feelings, behaviors, and thoughts.

Device: smartphone applications

Interventions

smartphone applications DEVICE

app is designed to help you learn relaxation skills.

Group 1 smartphone applications; Group 2 smartphone applications

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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-cig 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
• English speaking and ability to read and comprehend English, and 7) 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.

You may not qualify if:

• endorsing current suicidal ideation or intent,
• meeting criteria for a current Major Depressive Episode measured by the PHQ-9,
• 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.
• Pregnant women will not be excluded from participating in the study and any decisions about potential pharmacotherapy will be done as standard of care in the Tobacco Treatment Program, including a consultation with the medical team and a joint decision-making process with the patient to determine the best course of treatment given all co-morbid medical conditions.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Jennifer Minnix

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 9, 2021
• Study Start: April 12, 2019
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)