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Study Summary
No. 2004-0202:.......Psychosocial......Ellen R. Gritz......Behavioral Science
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Study Summary Title
Study Summary
Number:
2004-0202
Study Title:Predictors of Relapse to Smoking in Lung Cancer
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Physician New Patient Referral
Name:Ellen R. GritzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3187
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:N/A
Phase of Study:N/AReturn
Visit:
All follow-up assessments will be conducted over the phone. There will be no
return visits.
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Participants will be recruited while they are hospitalized for surgical
treatment of lung cancer. Length of stay will not be influenced by
participation in this study.
Description/
Intervention:
The goal of this psychosocial research study is to look at what factors make
quitting smoking harder or easier for lung cancer patients.
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Study Objectives / Outcomes
The purpose of this research is to evaluate the influence of individual variables on relapse to smoking among lung cancer patients with clinical stage I or II non-small cell lung cancer who smoked within 3 months prior to their referral for surgical evaluation and treatment. These variables include smoking history, healthy lifestyle, and personality variables such as impulsiveness, optimism, leading a "fast" or reckless lifestyle, or being neurotic. They also include patients' social support, and their urges to smoke and attitudes toward smoking. The research will examine the relationship among these variables to determine the extent to which patients relapse because of the perceived benefits of smoking compared with the discomfort of quitting. Dr. Ellen R. Gritz has been awarded a subcontract from Washington University to recruit participants in this currently ongoing study, Predictors of Relapse in Lung Cancer (Dr. Edwin B. Fisher, Principal Investigator).

The specific aims are

1. To evaluate the association of maintenance of cessation up to 3 years following surgery with variables of depression, anxiety, social support, nicotine dependence, and urges to smoke.

2. To test the relationship among social support, depression, and anxiety in relapse to smoking.

3. To test a measurement model of key constructs linking the variables above.

4. To evaluate the extent to which Aversive and Appetitive Urges, depression, anxiety, general social support, Nondirective and Directive support, and dependence are associated with two broad dimensions of motivation, Appetitive and Aversive Motives
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Study Status Information
Study Activation / Registration Date:08/25/2004
IRB Review and Approval Date:06/02/2004
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:344
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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) Received surgical treatment for clinical stage I or II non-small cell lung cancer

2) Must have smoked at least 100 cigarettes in their life

3) Must have smoked at least 1 cigarette within the 3 months previous to their referral to surgical care

4) Age 18 or older

5) Approached, recruited, and consented in unit where patient will be hospitalized following surgery

Exclusion Criteria:1) Inoperable or metastatic disease

2) Unwilling or unable to provide written informed consent to participate

3) Unable to complete measures and protocol due to severe cognitive impairment or confusion, insufficient ability to read and understand English, or otherwise unable to complete protocols

4) Refuse or not permitted by their surgeon or oncologist to participate

5) Other exclusions (e.g., comorbidities or current use of psychiatric medications) have not been planned in the interest of enhancing the ecological validity of the study. However, comorbidities will be included in the models to be tested. Also, medical treatment and medications will be included in the data set and remain available for inclusion in statistical analyses.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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