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A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients


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.


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, and

2. Had 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of recruitment and intervention completion.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Elyse Park, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

MGH

Authority:

United States: Institutional Review Board

Study ID:

2007p-000838

NCT ID:

NCT00580398

Start Date:

January 2008

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617