Quit Smoking Program for Lung Cancer Patients' Families (The Family Ties Project)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00345891|
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : July 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Coping-focused counseling telephone calls||Not Applicable|
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:
- 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.
- 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
- To evaluate the cost-effectiveness of the standard self-help and coping-focused interventions.
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 cessation.
All family members will be surveyed at baseline, 2 weeks, 6 months and 12- months follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||496 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quite Smoking Program for Lung Cancer Patients' Families|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
- 7-day point-prevalence abstinence at the 12-month follow-up and prolonged abstinence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345891
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute Thoracic Oncology Program|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|UNC Chapel Hill Multidisciplinary Thoracic Oncology Program|
|Chapel Hill, North Carolina, United States, 27599|
|Durham VAMC Medical Thoracic Oncology Clinic|
|Durham, North Carolina, United States, 27705|
|Duke University Medical Center Thoracic Oncology Program|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Lori A Bastian, MD, MPH||Duke University|