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Smoking Cessation Intervention for Thoracic Patients

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation counseling
varenicline
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A patient is eligible if he/she:

  1. Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis
  2. Smoked a cigarette in the past 2 weeks
  3. Is willing to make a pre-surgical quit attempt

Exclusion Criteria:

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Usual care included physician advice to quit smoking.

Intervention participants were provided with a cognitive-behavioral 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We offered 7 counseling sessions but were flexible in offering additional counseling when needed. Counseling was delivered by a certified Tobacco Treatment Counselor using Motivational Interviewing (MI) techniques.

Outcomes

Primary Outcome Measures

Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
Number of participants who completed the 12-week follow-up survey and thus the study.

Secondary Outcome Measures

Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
7-day point prevalence abstinence ("Have you smoked a cigarette, even a puff, in the past 7 days?") was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.

Full Information

First Posted
December 20, 2007
Last Updated
September 13, 2018
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00580398
Brief Title
Smoking Cessation Intervention for Thoracic Patients
Official Title
A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. The secondary aim is to assess smoking cessation rates 3 months following surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care included physician advice to quit smoking.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention participants were provided with a cognitive-behavioral 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We offered 7 counseling sessions but were flexible in offering additional counseling when needed. Counseling was delivered by a certified Tobacco Treatment Counselor using Motivational Interviewing (MI) techniques.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling
Other Intervention Name(s)
Motivational Interviewing
Intervention Description
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
Primary Outcome Measure Information:
Title
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
Description
Number of participants who completed the 12-week follow-up survey and thus the study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
Description
7-day point prevalence abstinence ("Have you smoked a cigarette, even a puff, in the past 7 days?") was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Smoked 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyse Park, Ph.D.
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21512406
Citation
Park ER, Japuntich S, Temel J, Lanuti M, Pandiscio J, Hilgenberg J, Davies D, Dresler C, Rigotti NA. A smoking cessation intervention for thoracic surgery and oncology clinics: a pilot trial. J Thorac Oncol. 2011 Jun;6(6):1059-65. doi: 10.1097/JTO.0b013e318215a4dc. Erratum In: J Thorac Oncol. 2011 Aug;6(8):1454.
Results Reference
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Smoking Cessation Intervention for Thoracic Patients

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