Smoking Cessation Treatment for Head & Neck Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01098955
First received: April 2, 2010
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Smoking Cessation
Behavioral: Acceptance and Commitment Therapy
Behavioral: Motivational and Behavioral Counseling
Drug: Varenicline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Smoking Abstinence Rate [ Time Frame: Baseline and 6 weeks (last counseling session) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 108
Study Start Date: March 2010
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT Group 1
Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.
Behavioral: Acceptance and Commitment Therapy
6 x 60-minute counseling sessions delivered over a 5-week period
Drug: Varenicline
2 mg daily for 12 weeks
Other Name: Chantix
Experimental: MBC Group 2
Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.
Behavioral: Motivational and Behavioral Counseling
6 x 60-minute counseling sessions delivered over a 5-week period
Drug: Varenicline
2 mg daily for 12 weeks
Other Name: Chantix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098955

Contacts
Contact: Jan Blalock, PhD 713-745-1728

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jan Blalock, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jan Blalock, PhD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01098955     History of Changes
Other Study ID Numbers: 2009-0362, NCI-2011-02004, 1R01CA120153-01A2
Study First Received: April 2, 2010
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Smoking Cessation Treatment
Acceptance and Commitment Therapy
ACT Theory
Motivational and Behavioral Counseling
MBC
abstinence
Varenicline
Chantix

Additional relevant MeSH terms:
Head and Neck Neoplasms
Smoking
Neoplasms by Site
Neoplasms
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014