Nicotine Dependence
Conditions
Keywords
smoking, teachable moment, cancer
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.
Interventions
DRUGTransdermal nicotine patch
8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
Sponsors
National Institutes of Health (NIH)
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual Rate (Eligibility Visit) | week zero | Show rate to eligibility visit |
Secondary
| Measure | Time frame |
|---|---|
| Smoking Cessation Rate | week nine |
| Show Rate at First Treatment Session | week one |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Relatives of Cancer Patients Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling. | 113 |
| Relatives of Orthopedic Patients Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling | 121 |
| Total | 234 |
Baseline characteristics
| Characteristic | Relatives of Cancer Patients | Relatives of Orthopedic Patients | Total |
|---|---|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 11.7 | 49.2 years STANDARD_DEVIATION 11.7 | 47.0 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 57 Participants | 70 Participants | 127 Participants |
| Sex: Female, Male Male | 56 Participants | 51 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 113 | 0 / 121 |
| serious Total, serious adverse events | 0 / 113 | 0 / 121 |
Outcome results
Primary
Accrual Rate (Eligibility Visit)
Show rate to eligibility visit
Time frame: week zero
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relatives of Cancer Patients | Accrual Rate (Eligibility Visit) | 85 participants |
| Relatives of Orthopedic Patients | Accrual Rate (Eligibility Visit) | 72 participants |
Secondary
Show Rate at First Treatment Session
Time frame: week one
Population: This analysis includes only a subset of participants who had not discontinued the study by week 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relatives of Cancer Patients | Show Rate at First Treatment Session | 61 participants |
| Relatives of Orthopedic Patients | Show Rate at First Treatment Session | 52 participants |
Secondary
Smoking Cessation Rate
Time frame: week nine
Population: The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relatives of Cancer Patients | Smoking Cessation Rate | 13 participants |
| Relatives of Orthopedic Patients | Smoking Cessation Rate | 16 participants |