Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers

January 18, 2023 updated by: M.D. Anderson Cancer Center

Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods

This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.

II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.

III. Compare the cost-effectiveness of the three treatment conditions.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.

GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.

GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.

After completion of study, participants are followed up at 3, 6, and 12 months.

Study Type

Interventional

Enrollment (Actual)

626

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smoked at least 100 cigarettes in lifetime
  • English or Spanish speaking
  • Currently smoking at least 5 cigarettes a day, on average
  • Willing to set a quit smoking date within a week of the enrollment

Exclusion Criteria:

  • Positive history of a medical condition that precludes use of the nicotine patch
  • Current use of nicotine replacement therapy (NRT)
  • Current use of other smoking cessation medications (e.g., Chantix or Zyban)
  • Pregnant or nursing
  • Enrolled in another smoking cessation study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (standard care)
Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.
Other: Laboratory Biomarker Analysis
Correlative studies
Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Experimental: Group II (enhanced care)
Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Other: Tobacco Cessation Counseling
Undergo smoking cessation counseling
Experimental: Group III (intensive care)
Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Other: Tobacco Cessation Counseling
Undergo smoking cessation counseling
Behavioral: Telephone-Based Intervention
Undergo telephone based smoking cessation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking abstinence rate
Time Frame: At 12 months
The primary method of analysis will be mixed-model logistic regression.
At 12 months
Cost-effectiveness
Time Frame: At 12 months
Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cotinine levels
Time Frame: At 12 months
Salivary cotinine will be measured using the NicAlert test system.
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

August 10, 2009

Primary Completion (Actual)

February 10, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2009-0336 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-00260 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA141628 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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