Evidence-Based Tobacco Cessation Strategies in Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title:

Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211196
• Other study ID #: IRB00021885
• Secondary ID: NCI-2014-01572CC
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.

Description:

PRIMARY OBJECTIVES:

I. To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies.

II. To test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics.

III. To test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use.

OUTLINE:

Patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.

After completion of study, patients are followed up at 1 month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with cancer who saw a provider will be eligible

Exclusion Criteria:

• Having a nurse or lab visit only

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• smoking cessation intervention
Receive evidence-based tobacco cessation strategies

Other:
• survey administration
Ancillary studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies	Will be estimated and 95% confidence intervals (CI) constructed.	Up to 1 month
Primary	Percentage reporting feeling very confident in their ability to counsel smokers	Will be estimated and 95% CI constructed.	Up to 1 month
Primary	Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies	Will be estimated and 95% CI constructed.	Up to 1 month
Primary	Proportion of oncology patients willing to complete a survey in an oncology clinic	Will be estimated and 95% CI constructed.	Up to 1 month
Primary	Proportion of patients who report that their provider asked about tobacco use during their visit	These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.	Up to 1 month
Primary	Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies	These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.	Up to 1 month