Smoking Cessation Treatment for Head & Neck Cancer Patients

NCT01098955 | Active Not Recruiting Early Phase 1 FDA Drug

• 3 other identifiers: 2009-0362NCI-2011-020041R01CA120153-01A2
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Smoking Cessation

Keywords

Cancer; Smoking Cessation Treatment; Acceptance and Commitment Therapy; ACT Theory; Motivational and Behavioral Counseling; MBC; abstinence; Varenicline; Chantix

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence Rate

  Participants will be assessed on a variety of interview, self-report, and biochemical measures at baseline, at key points during treatment (including end of treatment), and at 14-, and 26-weeks after the targeted quit date

  Baseline up to 6 weeks

Study Arms (2)

ACT Group 1

EXPERIMENTAL

Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.

Behavioral: Acceptance and Commitment Therapy; Drug: Varenicline

MBC Group 2

EXPERIMENTAL

Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.

Behavioral: Motivational and Behavioral Counseling; Drug: Varenicline

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

6 x 60-minute counseling sessions delivered over a 5-week period

ACT Group 1

Motivational and Behavioral Counseling BEHAVIORAL

6 x 60-minute counseling sessions delivered over a 5-week period

MBC Group 2

Varenicline DRUG

2 mg daily for 12 weeks

Also known as: Chantix

ACT Group 1; MBC Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anticipated hospitalization of 2 weeks or longer
• Planned total laryngectomy
• Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy
• Currently receiving other forms of smoking cessation treatment
• 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
• Currently pregnant or lactating
• Has received treatment in the TTP
• History or/current medical condition, or any other factor that , in the judgment of the PI would likely preclude completion of study requirements

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

  PMID: 35420700 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Smoking Cessation; Neoplasms

Interventions

Acceptance and Commitment Therapy; Behavior Therapy; Varenicline

Condition Hierarchy (Ancestors)

Neoplasms by Site; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Psychotherapy; Behavioral Disciplines and Activities; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Jan Blalock, PhD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 5, 2010
• Study Start: March 24, 2010
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)