Assessment of a Teachable Moment for Smoking Cessation (TM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00596440
First received: January 8, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Nicotine Dependence
Drug: Transdermal nicotine patch

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of a Teachable Moment for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • accrual rate [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking cessation rate [ Time Frame: one week ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: August 2007
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596440

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Robert Schnoll, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596440     History of Changes
Other Study ID Numbers: 805712, NIH R01CA126969
Study First Received: January 8, 2008
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking
teachable moment
cancer

ClinicalTrials.gov processed this record on October 23, 2014