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Assessment of a Teachable Moment for Smoking Cessation (TM)
This study is currently recruiting participants.
Verified by University of Pennsylvania, February 2009
First Received: January 8, 2008   Last Updated: February 5, 2009   History of Changes
Sponsors and Collaborators: University of Pennsylvania
National Institutes of Health (NIH)
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596440
  Purpose

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.


Condition Intervention
Nicotine Dependence
Drug: Transdermal nicotine patch

Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Assessment of a Teachable Moment for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • accrual rate [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking cessation rate [ Time Frame: one week ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 346
Study Start Date: August 2007
Estimated Study Completion Date: March 2012
Groups/Cohorts Assigned Interventions
1
Relatives of Cancer Patients
Drug: Transdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
2
Relatives of Orthopedic Patients
Drug: Transdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596440

Contacts
Contact: Lynne Kohler, BA 215-746-7162 lkohler@mail.med.upenn.edu
Contact: Robert Schnoll, PhD 215-746-7143 schnoll@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lynne Kohler, BA     215-746-7162     lkohler@mail.med.upenn.edu    
Contact: Robert A Schnoll, PhD     215-746-7143     schnoll@mail.med.upenn.edu    
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennslyvania ( Robert Schnoll )
Study ID Numbers: 805712, NIH R01CA126969
Study First Received: January 8, 2008
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00596440     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking
teachable moment
cancer

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 11, 2009