RECRUITING

Smartphone-delivered Scheduled Smoking with Compliance Facilitation As an Adjunct Cessation Therapy: a Feasibility Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.

Official Title

Smartphone-delivered Scheduled Smoking with Compliance Facilitation As an Adjunct Cessation Therapy: a Feasibility Study

Quick Facts

Study Start:2024-02-15

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05763771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age: 18 years old or older * Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen * Expired carbon monoxide (CO): \> 6 ppm * Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team * Agree to return the study smartphone if the participant loans one from the research team * Willing to reduce smoking (Aim 1) * Seeking smoking cessation treatment (Aim 2) * Fluency in spoken and written English * Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email * Provide informed consent and agree to all assessments and study procedures * Willing to refrain from the use of other nicotine/tobacco products for the duration of the study * Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs	* Taking psychotropic, anticonvulsive, or narcotic medication * Meet criteria for a current major depressive episode or suicidality according to the PHQ * Involved in current and imminent (within the next 45 days) smoking cessation activity * Women who are pregnant or breastfeeding * Shares the same address as a currently enrolled participant * Unwilling to use or allergic to nicotine patches (Aim 2) * Considered by the investigator to be an unsuitable or unstable candidate, such as those who appear to have cognitive impairment, and those who reside in a shelter, group/recovery facility, or treatment facility * Any plans to move out of the state in the next 6 months * Using marijuana, prescription medications not prescribed to the participant, and illegal drugs on a daily basis * Have experienced abnormal heart rhythms or cardiovascular disease, such as stroke, chest pain, and heart attack, in the last month (Aim 2)

Inclusion Criteria

Exclusion Criteria

* Age: 18 years old or older
* Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen
* Expired carbon monoxide (CO): \> 6 ppm
* Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team
* Agree to return the study smartphone if the participant loans one from the research team
* Willing to reduce smoking (Aim 1)
* Seeking smoking cessation treatment (Aim 2)
* Fluency in spoken and written English
* Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
* Provide informed consent and agree to all assessments and study procedures
* Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
* Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs

* Taking psychotropic, anticonvulsive, or narcotic medication
* Meet criteria for a current major depressive episode or suicidality according to the PHQ
* Involved in current and imminent (within the next 45 days) smoking cessation activity
* Women who are pregnant or breastfeeding
* Shares the same address as a currently enrolled participant
* Unwilling to use or allergic to nicotine patches (Aim 2)
* Considered by the investigator to be an unsuitable or unstable candidate, such as those who appear to have cognitive impairment, and those who reside in a shelter, group/recovery facility, or treatment facility
* Any plans to move out of the state in the next 6 months
* Using marijuana, prescription medications not prescribed to the participant, and illegal drugs on a daily basis
* Have experienced abnormal heart rhythms or cardiovascular disease, such as stroke, chest pain, and heart attack, in the last month (Aim 2)

Contacts and Locations

Study Contact

Yong Cui, PHD

CONTACT

(713) 792-7837

ycui1@mdanderson.org

Principal Investigator

Yong Cui, PHD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Yong Cui, PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-02-15

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Smoking