An observational study in Nicotine Dependence, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by University of Pennsylvania · Observational
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 234 is above the median of 128 across 74 observational studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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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).
Exclusion Criteria:
Relatives of Cancer Patients
Drug: Transdermal nicotine patch
Relatives of Orthopedic Patients
Drug: Transdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
Accrual Rate (Eligibility Visit)
Show rate to eligibility visit
Time frame: week zero
Smoking Cessation Rate
Time frame: week nine
Show Rate at First Treatment Session
Time frame: week one
| Milestone | Relatives of Cancer Patients | Relatives of Orthopedic Patients |
|---|---|---|
| Started | 113 | 121 |
| Showed to eligibility visit | 85 | 72 |
| Showed to first treatment session | 61 | 52 |
| Completed | 48 | 41 |
| Not completed | 65 | 80 |
Show rate to eligibility visit
| participants | Relatives of Cancer Patients | Relatives of Orthopedic Patients |
|---|---|---|
| Accrual Rate (Eligibility Visit) | 85 | 72 |
| participants | Relatives of Cancer Patients | Relatives of Orthopedic Patients |
|---|---|---|
| Smoking Cessation Rate | 13 | 16 |
| participants | Relatives of Cancer Patients | Relatives of Orthopedic Patients |
|---|---|---|
| Show Rate at First Treatment Session | 61 | 52 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relatives of Cancer Patients | — | 0/113 (0%) | 0/113 (0%) |
| Relatives of Orthopedic Patients | — | 0/121 (0%) | 0/121 (0%) |
| Age, Continuous(years) | Relatives of Cancer Patients | Relatives of Orthopedic Patients | Total |
|---|---|---|---|
| Mean | 44.7 ± 11.7 | 49.2 ± 11.7 | 47.0 ± 11.9 |
| Sex: Female, Male(Participants) | Relatives of Cancer Patients | Relatives of Orthopedic Patients | Total |
|---|---|---|---|
| Female | 57 | 70 | 127 |
| Male | 56 | 51 | 107 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania