MDACC Study Summary 2009-0362

Study Summary
No. 2009-0362:.......Breast; Gastrointestinal; Genitourinary; Head And Neck; Lung......Jan Blalock......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0362

Study Title:	Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy

Physician

New Patient Referral



Name:	Jan Blalock	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-1728 Contact us about clinical trials

General Information



Disease Group:	Breast Gastrointestinal Genitourinary Head And Neck Lung	Supported By:	National Cancer Institute

Phase of Study:	N/A	Return Visit:	7

Treatment Agents:	Smoking cessation counseling Varenicline	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable

Description/
Intervention:

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.

Study Objectives / Outcomes

Primary Aims
The aims of the first phase (Stage Ia) of the project are:
1. To develop a specialized intervention targeting smoking cessation in head and neck, lung, breast, gastrointestinal, or genitourinary cancer patients who continue to smoke following diagnosis, which is based on Acceptance and Commitment Therapy (ACT) theory and clinical methods. This work will include:
a. The development of clinician and participant manuals which will be based on the integration of brief ACT protocols and a current ACT protocol for treating psychological stress in gynecological cancer patients
b. The development of a parallel training program and training materials for therapists
c. The training of therapists to deliver the intervention

The aims of the second phase (Phase Ib) of the project are:
2. To conduct a preliminary randomized trial with head and neck, lung, breast, gastrointestinal, or genitourinary cancer patients who continue to smoke following diagnosis, comparing the ACT smoking cessation treatment (ACT) to standard motivational and behavioral counseling (MBC) to evaluate the following:
a. Primary Outcome
To examine the effects of ACT on both short and long-term point prevalence and prolonged abstinence
b. Secondary Outcome
To examine the effects of ACT on short and long-term quality of life

3. To assess mediation of the treatment effect on abstinence by hypothesized mediators of the ACT and MBC treatments when a significant treatment effect is found, or estimating the mediation effects if treatment effects appear promising yet are not significant due to small sample size; and to evaluate the specificity of mediators to the ACT and MBC treatment models. We expect that the treatment will be mediated by reductions in experiential avoidance related to smoking and smoking cessation, and reductions in mental disengagement, a form of avoidant coping. In addition, we expect that hypothesized ACT mediators will be influenced by ACT and not MBC; and that the hypothesized MBC mediators will be influenced by MBC and not ACT.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	03/24/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT01098955
Study Information on Clinical Trials Registry (clinicaltrials.gov)