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NCT01098955Active, not recruitingEarly phase 1

Smoking Cessation Treatment for Head & Neck Cancer Patients

Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer. This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy. In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling. This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy. The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
51 (actual)
First submitted
2 Apr 2010
Start date
24 Mar 2010
Primary completion date
30 Sept 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT01098955

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 51
  • From 24 Mar 2010 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy
  • Currently receiving other forms of smoking cessation treatment
  • Has received treatment in the TTP

Other illness

  • Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to psychiatric disorders that place participant at risk for harm or require immediate treatment
  • History or/current medical condition, or any other factor that , in the judgment of the PI would likely preclude completion of study requirements

Other

  • Anticipated hospitalization of 2 weeks or longer
  • Planned total laryngectomy
  • Currently pregnant or lactating

Who the study is looking for

  • Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer
  • Age 18 or older
  • Smoking 1 cigarette or more per day at screening visit
  • English speaking and have a telephone
  • Willing to provide informed consent and agree to all assessments and study procedures
  • Recommended for and agreed to treatment with varenicline through the Tobacco Treatment Program
  • Plan to receive treatment for head and neck, lung, breast, gastrointestinal, or genitourinary cancer, currently undergoing treatment, or in follow-up care at M.D. Anderson Cancer Center

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas - MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.