ClinicalTrials.gg
Active, not recruitingNCT01788787Updated May 28, 2019

Ask Advise Connect (AAC) Harris Heath CPRIT

An observational study in Tobacco Use Cessation, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,212
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Study Test:

If you agree to take part in this study, you will collect a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for the testing. The study staff will call you to make sure that you received the kit and to discuss the instructions with you. To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will mail the saliva sample back to the study staff, using a postage-paid envelope.

Length of Study:

Your participation in this study will be complete after you collect the saliva sample and mail it back to the study staff. Study data will be destroyed 5 years after the study has been completed and the data has been analyzed. Data collected in this study will not be used for future research.

This is an investigational study.

Up to 1,459 participants will be enrolled in this study. All will be enrolled at Harris Health System clinics.

02

Conditions studied

  • Tobacco Use Cessation

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Keywords

  • Cancer Prevention
  • Tobacco Use Cessation
  • Ask Advise Connect
  • AAC
  • Smoking Cessation Treatment
  • Texas Quitline
  • Saliva sample
  • Telephone Counseling
  • Nicotine replacement
  • Interviews
03

In context

Tobacco Use Cessation

68 studies on the registry are indexed under Tobacco Use Cessation; 31 are open to participants now.

Browse Tobacco Use Cessation studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients from the Harris Health System Community Health Clinics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18 years of age or older
  2. Self-reported current smoker
  3. Present for care at one of the 13 Harris Health System (HHS) community clinics
  4. Has a working telephone number

Exclusion criteria

Exclusion Criteria:

1) None

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,212 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Texas Quitline

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

    Behavioral: Quitline-Delivered Proactive Telephone Counseling · Behavioral: Follow-Up Phone Call

  • Training Providers

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

    Behavioral: Smoking Cessation Training · Behavioral: Qualitative Interviews Concerning the Implementation of AAC

Interventions

  • BehavioralQuitline-Delivered Proactive Telephone Counseling

    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.

  • BehavioralFollow-Up Phone Call

    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.

  • BehavioralSmoking Cessation Training

    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.

  • BehavioralQualitative Interviews Concerning the Implementation of AAC

    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.

06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. Efficacy of Ask Advise Connect (AAC) Smoking Cessation Program

    Efficacy is defined as the proportion of smokers who agree to be connected to the Quitline that enroll in treatment who successfully achieve abstinence assessed 6 months following treatment enrollment.

    Time frame: 6 months

07

Study locations

1 site
  • Harris Health System
    Houston, Texas 77030, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2013 (actual). Primary completion is estimated for Apr 2049, 432 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2013
First posted
Feb 11, 2013
StartActual
Apr 2013
Primary completionEst.
Apr 2049
CompletionEst.
Apr 2049
Last update
May 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01788787
Collaborators
Cancer Therapy and Research Center, Texas
Responsible party
Sponsor
First posted
Feb 11, 2013
Start date
Apr 2013
Primary completion
Apr 2049 (estimated)
Completion
Apr 2049 (estimated)
Last update
May 28, 2019

Study contacts

Lorna H. McNeill, PHD, MPH
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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