Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

NCT ID: NCT04738643

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 685 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-01-24

Brief Summary

The research objective is to identify a simple, pragmatic, innovative way of enhancing Tobacco Use Treatment (TUT) rates within oncology. To investigate this possibility, the investigators propose methods that will allow them to: 1) evaluate the impact of standing orders to initiate a varenicline management protocol within outpatient cancer treatment workflow, 2) assess the potential for an EHR-based intervention to affect patient TUT behaviors, and 3) identify important facilitators and barriers that impact effectiveness of the intervention.

The investigators will assess whether including a standing order for prescription and management of varenicline (TUT Service+VM) within the workflow for cancer patients identified as current smokers will significantly increase TUT engagement rates compared to current standard of care (TUT Service alone). The investigators hypothesize that observed treatment engagement rates will be higher among clinicians exposed to TUT Service+VM than observed in clinicians exposed to TUT Service alone.

Detailed Description

To reduce all-cause and cancer-specific mortality, the 2014 Surgeon General's Report emphasized the importance of effective tobacco use treatment (TUT) in cancer care. Unfortunately, up to 50% of cancer patients who smoke prior to their diagnosis continue to do so after diagnosis and treatment. This observation has lead the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the American Association for Cancer Research to call for implementation strategies integrating TUT directly within oncology care. At this time, many cancer centers and oncology practices fall short of providing consistent, high-quality TUT; only half of cancer centers report that they identify tobacco use among patients, and very few use systematic mechanisms to encourage TUT services.

In response, the National Cancer Institute (NCI) funded the Cancer Center Cessation Initiative (C3I) in 2017 with support from the NCI Cancer Moonshot Program. C3I's aim is to help build and sustain TUT infrastructure across the nation's cancer centers, ensuring that cancer patients are systematically screened for tobacco use and provided with evidence-based smoking cessation treatment. Abramson Cancer Center's work implementing the C3I tobacco use treatment service (TUT Service) has significantly improved rates of TUT within oncology practice, however the investigators have identified a number of important social-motivational obstacles to reaching the target of universal TUT. For instance, it is known that simple changes to treatment choice architecture in the electronic health record (EHR), i.e. utilizing an "opt-out" rather than "opt-in" structure, increases TUT Service engagement in a manner similar to other contexts of cancer care. Unfortunately, there remains unacceptable variation in clinician engagement rates. One significant reason for this variation is the individual clinician's perceptions of treatment effectiveness.( A strategy used elsewhere involved utilizing opt-out orders aimed at maximizing the use of varenicline, i.e. "Varenicline Management" (VM). VM resulted in increased clinician utilization and patient cessation within a relatively controlled environment of hospital-based cardiac and pulmonary care. However, it is unknown whether this type of intervention is generalizable to the complex, challenging environment of outpatient oncology.

The goal of this study is to determine if the default for a varenicline order increases clinician referral to TUTS and/or the treatment of tobacco use. At this point, many clinicians are turning the referral order off and patients are not receiving treatment for tobacco use. A default to prescribe treatment may help override barriers to both.

Insights gained from this project form the basis of subsequent clinical trials assessing efficacy of novel implementation approaches improving uptake of evidence-based tobacco use treatment. This study is significant because the model for promoting physician behavior change is simple and pragmatic, yet has the potential to significantly impact cancer patient survival and morbidity. The study builds on previous observations made through NCI and C.U.R.E. investments, expanding the understanding of novel pharmacologic approaches to tobacco cessation.

Conditions

Cancer; Tobacco Use; Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

TUT Service Only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tobacco Use Treatment Service + Varenicline Management

TUTS + Varenicline Management

Group Type: EXPERIMENTAL

Tobacco Use Treatment Service and Varenicline Management

Intervention Type: OTHER

The VM intervention builds upon the established TUT Service process. In addition to connecting the patient to TUT Service via electronic referral, it activates a medication management protocol that: 1) actively confirms no evidence of renal failure or pregnancy with oncology provider, 2) automates a referral to prescribing providers within the TUT Service team, prompting a call-back to patient within 24 hours, 3) provides written AVS instructions to contact TUT Service for initiation instructions and clinic appointment, and 4) pends a varenicline prescription to the medication list, ready for reconciliation by TUT Service prescribing clinicians. The protocol formalizes standard management principles for varenicline, including follow-up evaluation, pre-quit period duration, and side effect amelioration.

Interventions

Tobacco Use Treatment Service and Varenicline Management

The VM intervention builds upon the established TUT Service process. In addition to connecting the patient to TUT Service via electronic referral, it activates a medication management protocol that: 1) actively confirms no evidence of renal failure or pregnancy with oncology provider, 2) automates a referral to prescribing providers within the TUT Service team, prompting a call-back to patient within 24 hours, 3) provides written AVS instructions to contact TUT Service for initiation instructions and clinic appointment, and 4) pends a varenicline prescription to the medication list, ready for reconciliation by TUT Service prescribing clinicians. The protocol formalizes standard management principles for varenicline, including follow-up evaluation, pre-quit period duration, and side effect amelioration.

Intervention Type: OTHER

Other Intervention Names

TUTS + VM; TUT Service + VM

Eligibility Criteria

Inclusion Criteria

1. Currently in active practice within Medical and Radiation Oncology divisions of ACC,

2. Prescribing authority in Pennsylvania (i.e. physician, nurse practitioner, physician assistant),

3. Nonsmoker,

4. Has cared for at least one patient with tobacco use disorder in the 30 days prior to recruitment,

5. English speaking, and

6. Willing to provide informed consent to participate.

Exclusion Criteria

1. Unwillingness to prescribe varenicline, or

2. Unwillingness to assign varenicline management to TUT Service providers.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SAP#4100083101

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

832404

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 04019

Identifier Type: -

Identifier Source: org_study_id