Clinical trial NCT00596440: Assessment of a Teachable Moment for Smoking Cessation
Official title: Assessment of a Teachable Moment for Smoking Cessation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nicotine Dependence
Keywords: smoking
teachable moment
cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-17
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Accrual Rate (Eligibility Visit)
timeFrame: week zero
Secondary outcomes:
measure: Smoking Cessation Rate
timeFrame: week nine
measure: Show Rate at First Treatment Session
timeFrame: week one
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert A Schnoll, PhD
role: PRINCIPAL_INVESTIGATOR
References: