Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Cancer; Tobacco Use; Nicotine Dependence
• Intervention / Treatment: Other: Tobacco Use Treatment Service and Varenicline Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Schnoll, PhD; Phone Number: 215-746-7143; Email: schnoll@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Frank Leone, MD, MS; Phone Number: 215-662-8585; Email: Frank.Leone2@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; TUT Service Only
Experimental: Tobacco Use Treatment Service + Varenicline Management; TUTS + Varenicline Management	Other: 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.; Other Names: TUTS + VM; TUT Service + VM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement Rate	Defined as the number of orders signed by the clinician, divided by the total number pended orders (1-cancellation rate).	Up to 30 days after Initial Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment Rate	Defined as number of times the BPA is satisfied with any answer, divided by the total number of times the BPA fires	Up to 30 days after Initial Visit
Prescription Rate	Defined as the number of pended orders accompanied by a signed prescription order for any of the 7 FDA-approved medications sent to pharmacy, divided by the total number of pended orders.	Up to 30 days after Initial Visit
Referral Rate	Defined as number of quit line referrals made, divided by the total number of TUT Service engaged patients.	Up to 30 days after Initial Visit
Treatment Initiation Rate	Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of 7 recommended tobacco dependence pharmacotherapies within 30 days of the initial ACC visit, divided by the total number of engaged patients.	30 Day Follow-up Assessment
QuitLine Rate	Defined as the total number of patients who present for quit line counseling (i.e. telephone or electronic), divided by the total number of engaged patients	30 Day Follow-up Assessment
Quit Attempt Rate	Defined as the number of engaged patients who make any quit attempt, divided by the total number of engaged patients	30 Day Follow-up Assessment
Abstinence Rate	Defined as the total number of engaged patients self-reporting 7-day point prevalence abstinence at a 30-day follow-up assessment.	30 Day Follow-up Assessment

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Smoking; Tobacco Use; Nicotine Dependence; Tobacco Use Treatment Service
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 832404; SAP#4100083101 (Other Grant/Funding Number: Commonwealth of Pennsylvania)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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