~1 spots leftby Sep 2025

Smoking Cessation Treatment for Head & Neck Cancer Patients

Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: M.D. Anderson Cancer Center
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

JB

Jan Blalock, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking adults over 18 with a current or past diagnosis of head and neck, lung, breast, gastrointestinal, or genitourinary cancer who smoke. They must be recommended for varenicline treatment and able to consent to study procedures. Exclusions include planned long hospital stays, certain surgeries, use of specific smoking cessation drugs or treatments, severe depression or psychiatric risk factors.

Inclusion Criteria

I am receiving or plan to receive cancer treatment at M.D. Anderson for specific cancers.
I have or had cancer in my head, neck, lung, breast, stomach area, or reproductive organs.
I speak English and have a phone.
See 4 more

Exclusion Criteria

I am currently using bupropion, nortriptyline, clonidine, or nicotine replacement therapy.
I have received treatment in the time to progression.
I am scheduled for a complete removal of my voice box.
See 5 more

Treatment Details

Interventions

  • Acceptance and Commitment Therapy (Behavioural Intervention)
  • Motivational and Behavioral Counseling (Behavioural Intervention)
  • Varenicline ()
Trial OverviewThe study compares two types of counseling: Acceptance and Commitment Therapy (investigational) versus Motivational and Behavioral Counseling (standard). It aims to determine which is more effective in helping patients quit smoking alongside their prescribed varenicline treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: MBC Group 2Experimental Treatment2 Interventions
Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.
Group II: ACT Group 1Experimental Treatment2 Interventions
Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+
Dr. Peter WT Pisters profile image

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee profile image

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School