Evidence-Based Tobacco Cessation Strategies in Patients With Cancer

Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: questionnaire administration; Other: survey administration; Behavioral: smoking cessation intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Having a nurse or lab visit only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Services Research (smoking cessation intervention); Participants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.	Other: questionnaire administration; Ancillary studies; Other: survey administration; Ancillary studies; Behavioral: smoking cessation intervention; Receive evidence-based tobacco cessation strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage reporting feeling very confident in their ability to counsel smokers	Will be estimated and 95% CI constructed.	Up to 1 month
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
Proportion of oncology patients willing to complete a survey in an oncology clinic	Will be estimated and 95% CI constructed.	Up to 1 month
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Erin Sutfin, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00021885; P30CA012197 (U.S. NIH Grant/Contract); NCI-2014-01572 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU #99413 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No