Assessment of a Teachable Moment for Smoking Cessation (TM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00596440
First received: January 8, 2008
Last updated: January 14, 2013
Last verified: January 2013

January 8, 2008
January 14, 2013
August 2007
December 2011   (final data collection date for primary outcome measure)
accrual rate [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00596440 on ClinicalTrials.gov Archive Site
smoking cessation rate [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of a Teachable Moment for Smoking Cessation
Assessment of a Teachable Moment for Smoking Cessation

A teachable moment (TM) refers to life events or transitions, such as physician visits, early detection screening feedback, pregnancy, and hospitalization for, and diagnosis of, disease, that inspire health behavior change. Despite strong intuitive appeal of the TM concept and over 150 studies of interventions implemented in a TM, there has been little investigation of the influence of TMs for smoking, particularly for promoting smoking cessation among those indirectly affected by a TM (e.g., relatives of cancer patients). This prospective observational study using a matched-group design will assess whether a lung cancer diagnosis increases enrollment in a smoking cessation program and cessation, and reduces smoking, among the patient's relatives/spouse who smoke. We will compare enrollment in a cessation program and cessation and smoking rates in 2 groups of smokers: 1) relatives/spouses of newly-diagnosed lung cancer patients, and 2) relatives/spouses of patients with an orthopedic condition. We will also explore mediators and moderators of a lung cancer diagnosis as a TM. This study could clarify the TM concept for smoking cessation, shed light on the underlying mechanisms of TMs, and guide future development and implementation of TM-based smoking cessation interventions.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

One group will be relatives/spouses of newly-diagnosed lung or head and neck cancer patients and the second group will be relatives/spouses of orthopedic patients. All participants will be regular smokers (i.e., smoke 10 cigarettes/day on average).

Nicotine Dependence
Drug: Transdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
  • 1
    Relatives of Cancer Patients
    Intervention: Drug: Transdermal nicotine patch
  • 2
    Relatives of Orthopedic Patients
    Intervention: Drug: Transdermal nicotine patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A relative (i.e., sibling, parent, child, grandparent, aunt, uncle, cousin) or spouse of a newly-diagnosed lung or head and neck cancer patient or orthopedic patient (e.g., arthritis, bone and joint infection, foot and ankle conditions, hand, wrist, and elbow conditions such as carpal tunnel syndrome, shoulder and elbow conditions, such as rotator cuff injury, and knee conditions, such as ligament damage repair);
  2. A regular smoker (i.e., smoke 10 cigarettes/day on average);
  3. Able to use NRT (see contraindications under Key Exclusion Criteria);
  4. Age 18 or older (to use NRT); and
  5. Living within ~50 miles of PENN (to allow for meetings at PENN).

Exclusion Criteria:

  1. Cannot communicate in English;
  2. Have current alcohol abuse/dependence;
  3. Are or have been diagnosed with cancer, asthma, HIV, emphysema, or COPD;
  4. Have a current medical problem for which NRT is contraindicated such as uncontrolled hypertension (> 150 over 90), unstable angina, heart attack or stroke within the past 6 months, and liver and/or kidney failure in the last 6-months;
  5. Currently use monoamine oxidase inhibitors or benzodiazepines, anti-psychotics, and antidepressants, including bupropion;
  6. Are allergic to adhesive tape or latex, and
  7. Are a female who is pregnant or nursing.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596440
805712, NIH R01CA126969
No
Robert Schnoll, University of Pennsylvania
University of Pennsylvania
National Institutes of Health (NIH)
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
University of Pennsylvania
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP