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Smoking Cessation Treatment for Head & Neck Cancer Patients

NCT01098955 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jennifer Minnix, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-24
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098955 on ClinicalTrials.gov