The recently released 2014 Surgeon General's Report concluded that smoking causes adverse outcomes in cancer patients, and the effects of smoking affect all disease sites and cancer treatment modalities (surgery, chemotherapy, and radiotherapy [RT]). However, most cancer patients do not receive evidence-based cessation support to quit smoking, in part due to several provider-level barriers. Opt-out strategies to clinical care, where all patients are automatically referred to a clinical care program and can later choose not to participate, is one potentially effective method to remove provider-related barriers to evidence-based care. The investigators have piloted large opt-out strategies in cancer patients demonstrating that more than 90% of smoking cancer patients referred through an opt-out strategy are willing to participate in an evidence-based smoking cessation program, while few (1%) participate using an opt-in approach. The objective of this study is to evaluate i an opt-out strategy (vs. opt-in or usual care) can effectively increase smoking cessation rates in cancer patients who smoke at the time of initial consultation for cancer treatment in a radiotherapy clinic. To test this hypothesis, we will randomize 276 patients to an opt-out vs. opt-in strategy for cessation support that provides evidence-based smoking cessation support according to newly released National Comprehensive Cancer Network (NCCN) Guidelines. The primary outcome for Specific Aim 1 (SA1) will be to evaluate smoking cessation rates between each arm with a secondary analysis of adherence to an individualized cessation plan.
Specific Aim 2 (SA2) will evaluate the effects of smoking cessation on health-related quality of life (HRQOL) in each arm.
Specific Aim 3 (SA3) will evaluate the effect of patient specific moderators on smoking cessation rates in each arm. The results of the proposed study could directly impact evidence-based standards of care for cancer patients and justify consideration of an opt-out approach to improving delivery of other evidence-based care for a spectrum of patients with chronic comorbid diseases such as cancer.

Public Health Relevance

Though smoking causes adverse outcomes for cancer patients, most cancer patients do not receive evidence-based support for smoking cessation. This study will test if an 'opt-out' strategy to smoking cessation significantly improves cessation rates as compared with an 'opt-in' (usual care) approach. This study will further evaluate the effects of smoking cessation on quality of life and evaluate patient moderators of cessation efficacy in both arms.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS024533-03
Application #
9402579
Study Section
Healthcare Effectiveness and Outcomes Research (HEOR)
Program Officer
Ganiats, Theodore
Project Start
2016-04-01
Project End
2021-01-31
Budget Start
2018-02-01
Budget End
2019-01-31
Support Year
3
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Medical University of South Carolina
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29403