Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 6:42 PM
Study NCT ID:
NCT01457469
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2011-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
Status:
COMPLETED
Status Verified Date:
2018-07
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:
This randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking
Detailed Description:
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting.
SECONDARY OBJECTIVES:
I. To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications.
II. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung \[FACT-L\] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module \[EORTC QLQ LC13\]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale \[CESD-10\]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (closed to accrual as of 3/6/2012): Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet.
ARM II: Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.
After completion of study treatment, patients are followed up at 3 months.
I. To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting.
SECONDARY OBJECTIVES:
I. To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications.
II. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung \[FACT-L\] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module \[EORTC QLQ LC13\]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale \[CESD-10\]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (closed to accrual as of 3/6/2012): Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet.
ARM II: Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.
After completion of study treatment, patients are followed up at 3 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: