Smoking CessationNCT00345891
Quit Smoking Program for Lung Cancer Patients' Families (The Family Ties Project)
A study testing Coping-focused counseling telephone calls in people with Smoking Cessation, run by Duke University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Coping-focused counseling telephone calls
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 496 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lung cancer
- Ages 18 or older
- Able to consent
- Patient has given consent to contact the family member
- Ages 18 or older
- Speaks and reads English
Show all 10Show fewer
- 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
Who cannot join
- Patients or family members who do not meet inclusion criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UNC Chapel Hill Multidisciplinary Thoracic Oncology Program
Chapel Hill, North Carolina, 27599
Durham VAMC Medical Thoracic Oncology Clinic
Durham, North Carolina, 27705
Duke University Medical Center Thoracic Oncology Program
Durham, North Carolina, 27710
H. Lee Moffitt Cancer Center & Research Institute Thoracic Oncology Program
Tampa, Florida, 33612
About this study
Official title: Quite Smoking Program for Lung Cancer Patients' Families
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.
Read the 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 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.
- Conditions
- Smoking Cessation
- Being tested
- Coping-focused counseling telephone calls
- Keywords
- Lung neoplasms, Family, Stress
- Medical subject headings
- Smoking Cessation, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping-focused counseling telephone callsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
Secondary outcomes (1)
7-day point-prevalence abstinence at the 12-month follow-up and prolonged abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startJun 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lori A Bastian, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345891
- Sponsor's protocol ID
- Pro00008930
- Other IDs
- U01CA092622
- Status last verified
- May 2010
- First submitted
- 27 Jun 2006
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Bastian LA, Fish LJ, Peterson BL, Biddle AK, Garst J, Lyna P, Molner S, Bepler G, Kelley M, Keefe FJ, McBride CM. Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Am J Health Promot. 2013 Jan-Feb;27(3):181-90. doi: 10.4278/ajhp.101122-QUAN-387.
PubMed 23286595
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quite Smoking Program for Lung Cancer Patients' Families
- ClinicalTrials.gov ID
- NCT00345891
- Acronym / sponsor ID
- Pro00008930
- Conditions
- Smoking Cessation
- Keywords
- Lung neoplasms, Family, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of lung cancer
- Ages 18 or older
- Able to consent
- Patient has given consent to contact the family member
- Ages 18 or older
Key exclusion criteria (1 listed)
- Patients or family members who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping-focused counseling telephone calls | Behavioural | – |
Primary outcome
7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
1 secondary outcome
7-day point-prevalence abstinence at the 12-month follow-up and prolonged abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 23286595Bastian LA, Fish LJ, Peterson BL, Biddle AK, Garst J, Lyna P, Molner S, Bepler G, Kelley M, Keefe FJ, McBride CM. Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Am J Health Promot. 2013 Jan-Feb;27(3):181-90. doi: 10.4278/ajhp.101122-QUAN-387.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Bastian, MD, MPH principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping-focused counseling telephone calls in people with Smoking Cessation, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point-prevalence abstinence at 2 weeks and 6 month follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.