Assessment of a Teachable Moment for Smoking Cessation (TM)

• ClinicalTrials.gov Identifier: NCT00596440
• Recruitment Status: Completed
• First Posted: January 17, 2008
• Results First Posted: June 11, 2015
• Last Update Posted: August 28, 2015
• Sponsor: University of Pennsylvania
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Robert Schnoll, University of Pennsylvania

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Nicotine Dependence	Drug: Transdermal nicotine patch

Study Design

• Study Type: Observational
• Actual Enrollment: 234 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Assessment of a Teachable Moment for Smoking Cessation
• Study Start Date: August 2007
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: February 2012

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Accrual Rate (Eligibility Visit) [ Time Frame: week zero ]
   Show rate to eligibility visit

Secondary Outcome Measures :

1. Smoking Cessation Rate [ Time Frame: week nine ]
2. Show Rate at First Treatment Session [ Time Frame: week one ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 805712; NIH R01CA126969
• First Posted: January 17, 2008
• 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