NCT01788787

Brief Summary

The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas Quitline.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,212

participants targeted

Target at P75+ for all trials

Timeline
278mo left

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Apr 2013Apr 2049

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
36 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2049

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2049

Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

36 years

First QC Date

February 7, 2013

Last Update Submit

May 23, 2019

Conditions

Tobacco Use Cessation

Keywords

Cancer PreventionTobacco Use CessationAsk Advise ConnectAACSmoking Cessation TreatmentTexas QuitlineSaliva sampleTelephone CounselingNicotine replacementInterviews

Outcome Measures

Primary Outcomes (1)

  • Evaluate the Reach of Ask Advise Connect (AAC) Smoking Cessation Program

    Reach defined as the proportion of smokers that enroll in treatment with the Quitline. To evaluate the reach of AAC, we will calculate the proportion of smokers seen at the 13 Harris Health System community health clinics during the two-year treatment dissemination period that enroll in treatment with the Quitline.

    2 years

Secondary Outcomes (1)

  • Efficacy of Ask Advise Connect (AAC) Smoking Cessation Program

    6 months

Study Arms (2)

Texas Quitline

Patients interested in smoking cessation treatment by calling the Texas Quitline.

Behavioral: Quitline-Delivered Proactive Telephone CounselingBehavioral: Follow-Up Phone Call

Training Providers

Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians).

Behavioral: Smoking Cessation TrainingBehavioral: Qualitative Interviews Concerning the Implementation of AAC

Interventions

Quitline-Delivered Proactive Telephone CounselingBEHAVIORAL

Smokers who enroll in treatment receive standard counseling protocol offered by the Quitline. This includes up to five proactive telephone counseling calls, each designed to provide practical expert support to help smokers develop problem-solving and coping skills, secure social support, and design a plan for successful cessation and long-term abstinence.

Texas Quitline
Follow-Up Phone CallBEHAVIORAL

Six months after enrolling in treatment with the Texas Quitline, an MD Anderson research team member will contact patients to assess their smoking status via telephone.

Texas Quitline
Smoking Cessation TrainingBEHAVIORAL

Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians) receive initial face-to-face group training on how to ask patients about their smoking status, advise them to quit, and connect them with the Quitline. The specific content of the session will include information on quitting smoking, how to implement AAC, the effectiveness of telephone counseling for smoking cessation delivered via quitlines, and pharmacotherapies including nicotine replacement.

Training Providers
Qualitative Interviews Concerning the Implementation of AACBEHAVIORAL

MD Anderson staff conduct individual in-depth interviews with administrative leadership as well as those medical staff who are authorized to enter patient information into the EMR and are trained in the Ask-Advise-Connect approach. All in-depth interviews will be recorded and transcribed.

Training Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Harris Health System Community Health Clinics

You may qualify if:

  • years of age or older
  • Self-reported current smoker
  • Present for care at one of the 13 Harris Health System (HHS) community clinics
  • Has a working telephone number

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harris Health System

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample to test for cotinine.

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Lorna H. McNeill, PHD, MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

April 1, 2013

Primary Completion (Estimated)

April 1, 2049

Study Completion (Estimated)

April 1, 2049

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

US(1)