Clinical trial NCT00948129: Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers
Official title: Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoker
Current Every Day Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-29
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking abstinence rate
timeFrame: At 12 months
measure: Cost-effectiveness
timeFrame: At 12 months
Secondary outcomes:
measure: Salivary cotinine levels
timeFrame: At 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alexander V Prokhorov
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidrine DJ, Frank-Pearce SG, Vidrine JI, Tahay PD, Marani SK, Chen S, Yuan Y, Cantor SB, Prokhorov AV. Efficacy of Mobile Phone-Delivered Smoking Cessation Interventions for Socioeconomically Disadvantaged Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):167-174. doi: 10.1001/jamainternmed.2018.5713.
citation: Daly AT, Deshmukh AA, Vidrine DJ, Prokhorov AV, Frank SG, Tahay PD, Houchen ME, Cantor SB. Cost-effectiveness analysis of smoking cessation interventions using cell phones in a low-income population. Tob Control. 2019 Jan;28(1):88-94. doi: 10.1136/tobaccocontrol-2017-054229. Epub 2018 Jun 9.
citation: Vidrine DJ, Fletcher FE, Danysh HE, Marani S, Vidrine JI, Cantor SB, Prokhorov AV. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION. BMC Public Health. 2012 Aug 25;12:696. doi: 10.1186/1471-2458-12-696.