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Completed

NCT Number: NCT00948129

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

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.

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Key information

Conditions

Cigarette Smoker Current Every Day Smoker

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Smoking Cessation Intervention

Behavioral

Undergo standard of care smoking cessation intervention

Other names: Smoking and Tobacco Use Cessation Interventions

Telephone-Based Intervention

Behavioral

Undergo telephone based smoking cessation intervention

Tobacco Cessation Counseling

Other

Undergo smoking cessation counseling

Primary outcomes

  1. Smoking abstinence rate

    Time frame: At 12 months

    The primary method of analysis will be mixed-model logistic regression.

  2. 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.

Secondary outcomes

  1. Salivary cotinine levels

    Time frame: At 12 months

    Salivary cotinine will be measured using the NicAlert test system.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2009
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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