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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
Lori A Bastian, MD, MPH
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute Thoracic Oncology Program||Tampa, Florida 33612|
|UNC Chapel Hill Multidisciplinary Thoracic Oncology Program||Chapel Hill, North Carolina 27599|
|Duke University Medical Center Thoracic Oncology Program||Durham, North Carolina 27710|
|Durham VAMC Medical Thoracic Oncology Clinic||Durham, North Carolina 27705|