Assessment of a Teachable Moment for Smoking Cessation (TM)

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Drug: Transdermal nicotine patch

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual Rate (Eligibility Visit)	Show rate to eligibility visit	week zero

Secondary Outcome Measures

Outcome Measure	Time Frame
Smoking Cessation Rate	week nine
Show Rate at First Treatment Session	week one

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (ESTIMATE): January 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: cancer; smoking; teachable moment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 805712; NIH R01CA126969