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Assessment of a Teachable Moment for Smoking Cessation (TM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596440
First Posted: January 17, 2008
Last Update Posted: August 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of a Teachable Moment for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Robert Schnoll, University of Pennsylvania:

Primary Outcome Measures:
  • Accrual Rate (Eligibility Visit) [ Time Frame: week zero ]
    Show rate to eligibility visit


Secondary Outcome Measures:
  • Smoking Cessation Rate [ Time Frame: week nine ]
  • Show Rate at First Treatment Session [ Time Frame: week one ]

Enrollment: 234
Study Start Date: August 2007
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596440


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
  More Information

Responsible Party: Robert Schnoll, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596440     History of Changes
Other Study ID Numbers: 805712
NIH R01CA126969
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: May 27, 2015
Results First Posted: June 11, 2015
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Robert Schnoll, University of Pennsylvania:
smoking
teachable moment
cancer

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action