Smoking Cessation Treatment for Head & Neck Cancer Patients

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

1. Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer

2. Age 18 or older

3. Smoking 1 cigarette or more per day at screening visit

4. English speaking and have a telephone

5. Willing to provide informed consent and agree to all assessments and study procedures

6. Recommended for and agreed to treatment with varenicline through the Tobacco Treatment Program

7. 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

Exclusion Criteria:

1. Anticipated hospitalization of 2 weeks or longer

2. Planned total laryngectomy

3. Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy

4. Currently receiving other forms of smoking cessation treatment

5. 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

6. Currently pregnant or lactating

7. Has received treatment in the TTP

8. History or/current medical condition, or any other factor that , in the judgment of the PI would likely preclude completion of study requirements