Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00345891
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2006-06-27
Brief Title:
Quit Smoking Program for Lung Cancer Patients Families The Family Ties Project
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Quite Smoking Program for Lung Cancer Patients Families
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients
Detailed Description:
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 ones 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 relatives 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 interventions
Patient diagnosed with lung cancer will be contacted and asked to enumerate their relatives ie 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 N240 or Coping-focused self-help N240 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 eg 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 ie 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 patients 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
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 relatives 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 interventions
Patient diagnosed with lung cancer will be contacted and asked to enumerate their relatives ie 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 N240 or Coping-focused self-help N240 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 eg 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 ie 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA092622 | NIH | None | httpsreporternihgovquickSearchU01CA092622 |