p16 Methylation for Smoking Cessation

This study has been completed.
Sponsor:
Collaborators:
Durham VA Medical Center
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01038492
First received: December 23, 2009
Last updated: June 26, 2013
Last verified: March 2012
  Purpose

Smoking cessation is often difficult for smokers to achieve for a variety of reasons including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking cessation, and failure to perceive the risks associated with smoking. We argue that the most effective biomarkers to affect perceptions of harm, especially for lung cancer, are those that signal progression towards disease development Proposed is a pilot study of educating smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal of this pilot study is to assess the interest in study participation from the VA smoking population, as well as to determine the fraction of subjects who will complete the study to power a future larger trial. Interested patients will receive a 15 minute educational presentation on the function of p16 and its role in development of lung cancer. They will then be assessed for airway obstruction by hand-held spirometry followed by review of a questionnaire assessing their understanding of the presented information, their concern for developing lung cancer, and their desire to quit smoking. All patients will be offered smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum cups to take home and return with morning sputum samples by mail. Samples will be assessed for evidence of p16 methylation and patients will be informed of the results. Follow-up phone interviews will be performed at 2 to 4 weeks after patients have received their results by mail to assess their understanding of the results, and their desire to stop smoking. A final phone interview will occur approximately 3 months after the sputum testing to assess attempts to stop smoking as well as the patients continued understanding of their test results. For purposes of this pilot, we are interested primarily in the descriptive statistics (e.g., frequencies) associated with the outcome of each objective (e.g., how many expressed interest, how many returned the sputum samples).


Condition Intervention
Tobacco Use Disorder
Smoking Cessation
Lung Cancer
Behavioral: p16 Methylation and Lung Cancer Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Testing the Feasibility of Using an Epigenetic Marker, p16, to Promote Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To determine patient interest in finding out whether, through the testing of p16 methylation in their sputum, whether they are at increased or average risk for developing cancer [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To determine the percentage of patients who return their sputum for p16 methylation analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To determine the percentage of patients who complete the 1-month phone interview [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To determine the percentage of patients who complete the 3-month interview [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the percentage of patients who have a positive result for p16 methylation in their sputum, indicating they are at higher risk for developing lung cancer [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: p16 Methylation in Sputum Testing
  • Patients tested for smoking-related changes in their breathing
  • shown a presentation on development of lung cancer
  • complete a questionnaire on items from presentation, desire to have p16 methylation test, views regarding their health and lung cancer, current smoking habits, and demographic detail
  • given a sputum cup which they are asked to spit into on three consecutive mornings and then return to the lab for processing
  • a results letter is mailed to them and then followed up with a phone call at one month to discuss the results as well as any changes in their attitudes or smoking habits
  • patients are called again at three months and asked about any changes in their attitudes or smoking habits
Behavioral: p16 Methylation and Lung Cancer Education
  • patients shown a presentation on p16 methylation and the development of lung cancer, asked to complete a questionnaire on items from presentation, desire to have p16 methylation test, views regarding their health and lung cancer, current smoking habits, and demographic details
  • patients given a sputum cup which they are asked to spit into on three consecutive mornings and then return to the lab for processing
  • a results letter is mailed to them and then followed up with a phone call at one month to discuss the results as well as any changes in their attitudes or smoking habits
  • patients are called again at three months and asked about any changes in their attitudes or smoking habits.
Other Name: Lung cancer education

Detailed Description:

In the United States during 2007, ~ 213,380 people were expected to be diagnosed with lung cancer, and ~ 160,390 expected to die of the disease. Among those diagnosed with lung cancer, 79% to 90% are cigarette smokers. Overall, ~21% of adults in the U.S. smoke. The most important and cost-effective strategy for the prevention of lung cancer mortality is smoking avoidance and cessation. Smoking cessation is often difficult for smokers to achieve for a variety of reasons including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking cessation, and failure to perceive the risks associated with smoking. We argue that the most effective biomarkers to affect perceptions of harm, especially for lung cancer, are those that signal progression towards disease development. Prior to the development of lung cancer, there are genetic alterations in the bronchial epithelium. One such alteration is the methylation of the promoter region of Rb-p16 (p16) important in regulation of the G1-S transition of the cell cycle. Prior studies have shown that presence of the promoter methylation of p16 results in a 2-fold increase in risk of developing lung cancer in smokers with evidence of airway obstruction.

Proposed is a pilot study of educating smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal of this pilot study is to assess the interest in study participation from the VA smoking population, as well as to determine the fraction of subjects who will complete the study to power a future larger trial. Interested patients will receive a 15 minute educational presentation on the function of p16 and its role in development of lung cancer. They will then be assessed for airway obstruction by hand-held spirometry followed by review of a questionnaire assessing their understanding of the presented information, their concern for developing lung cancer, and their desire to quit smoking. All patients will be offered smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum cups to take home and return with morning sputum samples by mail. Samples will be assessed for evidence of p16 methylation and patients will be informed of the results. Follow-up phone interviews will be performed at 2 to 4 weeks after patients have received their results by mail to assess their understanding of the results, and their desire to stop smoking. A final phone interview will occur approximately 3 months after the sputum testing to assess attempts to stop smoking as well as the patients continued understanding of their test results. Patients will be compensated a total of $40.00 for completing the study. For purposes of this pilot, we are interested primarily in the descriptive statistics (e.g., frequencies) associated with the outcome of each objective (e.g., how many expressed interest, how many returned the sputum samples).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current smoker
  • >30 pack year history
  • FEV1/FVC<70%
  • patients in outpatient pulmonary clinics at Durham VAMC and general medicine outpatient clinics at Durham VA Hillandale Clinic

Exclusion Criteria:

  • diagnosis of head, neck, or lung cancer
  • diagnosis of psychosis or severe cognitive impairment
  • refusal to sign informed consent
  • severe speech or hearing impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038492

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Durham VA Medical Center
Cancer and Leukemia Group B
Investigators
Principal Investigator: Scott Shofer, MD, PhD Durham VA Medical Center/Duke University Medical Center
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01038492     History of Changes
Other Study ID Numbers: Pro00012350, 155923, 01344
Study First Received: December 23, 2009
Last Updated: June 26, 2013
Health Authority: United States: Department of Veterans Affairs
United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Smoking
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014