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Quite Smoking Program for Lung Cancer Patients' Families

18 Years
Not Enrolling
Smoking Cessation

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Trial Information

Quite Smoking Program for Lung Cancer Patients' Families

Despite the fact that lung cancer is attributed almost entirely to cigarette smoking and
smoking cessation substantially decreases the risk for lung cancer, many smokers are not
significantly motivated to quit smoking. A loved one's diagnosis of terminal lung cancer
diagnosis presents a time when relatives who smoke are in need of and may be especially
receptive to smoking cessation interventions.

The overarching aim of the study is to evaluate in a randomized trial the impact of
delivering a coping-focused intervention as an adjunct to a state-of-the-science self-help
program to promote smoking cessation among relatives of lung cancer patients. The specific
aims are as follows:

1. To evaluate the impact of a coping-focused self-help intervention on relatives' rates
of abstinence from cigarettes at 2 weeks, 6- and 12-months post-treatment follow-ups.

2. To evaluate whether any observed intervention effect on abstinence rates is mediated by
improvements in relative's cognitive appraisals specifically self-efficacy, and
perceived control over health outcomes, adaptive coping responses, and decreases in
stress and depression

3. To evaluate the cost-effectiveness of the standard self-help and coping-focused

Patient diagnosed with lung cancer will be contacted and asked to enumerate their relatives
(i.e., immediate family, extended family, spouses, and anyone perceived as family) and asked
the smoking status of each of these relatives. Patients will then be asked for permission
to send their relatives who smoke a letter that describes the study and provides a telephone
number to call to decline participation. Patients who are current smokers may receive
materials to help them stop smoking.

The relatives who do not call to decline participation will be contacted by the survey
company to ask them to participate in a telephone survey. If eligible and willing, verbal
consent will be obtained from relatives who smoke to complete the 20-30 minute baseline
survey. During the telephone contact, relatives will have the opportunity to decline to
complete the survey and to be further involved in the research study.

The first relative in a family who participates will be randomized to one of two
intervention arms: Standard self-help (N=240) or Coping-focused self-help (N=240). Once
randomized, patients will receive the following intervention:

STANDARD SELF-HELP: Relatives who smoke will receive a letter from the clinic where their
family member receives care to encourage smoking cessation and to introduce the study. A
tailored booklet that encourages the relative to quit smoking will introduce a self-help
quit kit (e.g., written cessation booklet, audio relaxation tape, over-the-counter nicotine
patches, if applicable).

COPING-FOCUSED SELF-HELP: Participants in this arm will receive a letter from the clinic
where their family member receives care (i.e. TOP, MTOP, or MTOC), tailored booklet and
self-help quit kit. In addition, these relatives will receive a total of six counseling
phone calls that will be delivered in tandem with the tailored materials. Optimally these
phone calls will be scheduled once a week for a total of six weeks in order to retain
participation and to encourage practice and use of skills covered during the phone calls.
All calls must be completed with a 12-week period. Each intervention component will
emphasize: the salience of the patient's diagnosis as a prompt for smoking cessation or to
maintain abstinence and the importance of coping in ways that promote successful smoking

All family members will be surveyed at baseline, 2 weeks, 6 months and 12- months follow-up.

Inclusion Criteria:

- Inclusion Criteria-Patients:

- Diagnosis of lung cancer

- Ages 18 or older

- Able to consent

Inclusion Criteria-Family Members:

- Patient has given consent to contact the family member

- Ages 18 or older

- Speaks and reads English

- Cognitively able to give consent to participate

- Has access to a telephone

- Smoked at least 100 cigarettes in his/her life

- Smoked any cigarettes in the prior 7 days at screening

Exclusion Criteria:

- Patients or family members who do not meet inclusion criteria

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

Principal Investigator

Lori A Bastian, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:

Pro00008930 (U01-CA092622)



Start Date:

June 2004

Completion Date:

December 2007

Related Keywords:

  • Smoking Cessation
  • Lung neoplasms
  • Family
  • Stress
  • Lung Neoplasms
  • Smoking



H. Lee Moffitt Cancer Center & Research Institute Thoracic Oncology ProgramTampa, Florida  33612
UNC Chapel Hill Multidisciplinary Thoracic Oncology ProgramChapel Hill, North Carolina  27599
Duke University Medical Center Thoracic Oncology ProgramDurham, North Carolina  27710
Durham VAMC Medical Thoracic Oncology ClinicDurham, North Carolina  27705