NCT00580398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 21, 2014

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

4.3 years

First QC Date

December 20, 2007

Results QC Date

May 15, 2013

Last Update Submit

September 13, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Biochemically-validated 7-day Point Prevalence Tobacco Abstinence

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

Usual care included physician advice to quit smoking.

Intervention

EXPERIMENTAL

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.

Behavioral: Smoking cessation counselingDrug: varenicline

Interventions

Smoking cessation counselingBEHAVIORAL

Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.

Also known as: Motivational Interviewing
Intervention
vareniclineDRUG

varenicline (1mg bid, with initial titration up over week 1) for 12 weeks

Also known as: Chantix
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 21512406RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Motivational InterviewingVarenicline

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Limitations and Caveats

The generalizability of the findings are limited by a single study site. The statistical power to detect differences was limited by the small sample size of this pilot study.

Results Point of Contact

Title
Elyse Park, Ph.D., MPH
Organization
Massachusetts General Hospital
epark@partners.org
617-724-6836

Study Officials

  • Elyse Park, Ph.D.

    MGH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Elyse Park, PhD, Principal Investigator

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 12, 2018

Results First Posted

November 21, 2014

Record last verified: 2018-09

Locations

US(1)