NCT00596440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

June 11, 2015

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

4.3 years

First QC Date

January 8, 2008

Results QC Date

May 27, 2015

Last Update Submit

August 20, 2015

Conditions

Keywords

smokingteachable momentcancer

Outcome Measures

Primary Outcomes (1)

  • Accrual Rate (Eligibility Visit)

    Show rate to eligibility visit

    week zero

Secondary Outcomes (2)

  • Smoking Cessation Rate

    week nine

  • Show Rate at First Treatment Session

    week one

Study Arms (2)

1

Relatives of Cancer Patients

Drug: Transdermal nicotine patch

2

Relatives of Orthopedic Patients

Drug: Transdermal nicotine patch

Interventions

8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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);
  • A regular smoker (i.e., smoke 10 cigarettes/day on average);

You may not qualify if:

  • Age 18 or older (to use NRT); and
  • Living within \~50 miles of PENN (to allow for meetings at PENN).
  • Cannot communicate in English;
  • Have current alcohol abuse/dependence;
  • Are or have been diagnosed with cancer, asthma, HIV, emphysema, or COPD;
  • 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;
  • Currently use monoamine oxidase inhibitors or benzodiazepines, anti-psychotics, and antidepressants, including bupropion;
  • Are allergic to adhesive tape or latex, and
  • Are a female who is pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmokingNeoplasms

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Robert Schnoll
Organization
University of Pennsylvania

Study Officials

  • Robert A Schnoll, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

August 28, 2015

Results First Posted

June 11, 2015

Record last verified: 2015-08

Locations