Assessment of a Teachable Moment for Smoking Cessation

Nicotine Dependence Clinical Trial

— TM  

Official title:

Assessment of a Teachable Moment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596440
• Other study ID #: 805712
• Secondary ID: NIH R01CA126969
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: August 20, 2015
• Start date: August 2007
• Est. completion date: February 2012

Study information

• Verified date: August 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• Transdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual Rate (Eligibility Visit)	Show rate to eligibility visit	week zero	No
Secondary	Smoking Cessation Rate		week nine	No
Secondary	Show Rate at First Treatment Session		week one	No