Smoking Cessation Intervention for Patients Undergoing Lung Surgery
Recruitment status was Active, not recruiting
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Purpose
The primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge. Secondary aims are to assess smoking cessation rates just prior to surgical treatment and 3 months following surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Behavioral: CBT |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients |
- Feasibility of recruitment and intervention completion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Behavioral: CBT
Combined CBT & pharmacotherapy
|
Detailed Description:
This is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus Varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery. The study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at Massachusetts General Hospital (MGH) in Boston. A patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt. Patients will be excluded from the control group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on Varenicline has been on Varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention. Patients will be excluded from the intervention group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking Varenicline for longer than three weeks 5) have been taking Bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A patient is eligible if he/she:
- Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and
- Had a cigarette in the past 2 weeks,
- Is willing to make a pre-surgical quit attempt.
Exclusion Criteria:
Patients will be excluded from the intervention group if they are:
- Non-English speaking,
- Determined medically ineligible by their surgeon,
- Suffering from psychosis or dementia
- Have been taking Varenicline for longer than three weeks
- Have been taking Bupropion (for smoking cessation purposes) for more than three weeks,
- Is otherwise unable to participate in the intervention.
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Elyse Park, Ph.D. | MGH |
More Information
No publications provided
| Responsible Party: | Elyse R Park, MGH |
| ClinicalTrials.gov Identifier: | NCT00580398 History of Changes |
| Other Study ID Numbers: | 2007p-000838, 1 R03 CA130722-01 |
| Study First Received: | December 20, 2007 |
| Last Updated: | September 18, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013