Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

NCT04738643 | Completed Results

• 3 other identifiers: UPCC 04019SAP#4100083101832404
• Study Type: interventional
• Target: 685
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Tobacco Use; Smoking; Nicotine Dependence

Keywords

Cancer; Smoking; Tobacco Use; Nicotine Dependence; Tobacco Use Treatment Service

Outcome Measures

Primary Outcomes (1)

• Intervention Ordering Rate

  Defined as the number of patients for whom any inpatient tobacco use treatment order is signed by a participating clinician, divided by the total number of patients in each arm for whom an order was pended and the alert fired

  Up to 30 days after Initial Visit

Secondary Outcomes (6)

• Inpatient Medication Ordering Rate

  Up to 30 days after Initial Visit

• Outpatient/Discharge Medication Ordering Rate

  Up to 30 days after Initial Visit

• TUTS Referral Rate

  Up to 30 days after Initial Visit

• Quit Line Rate

  30 Day Follow-up Assessment

• Medication Recommendation Rate

  30 Day Follow-up Assessment

Study Arms (2)

Usual Care

NO INTERVENTION

TUT Service Only

Tobacco Use Treatment Service + Varenicline Management

EXPERIMENTAL

TUTS + Varenicline Management

Other: Tobacco Use Treatment Service and Varenicline Management

Interventions

Tobacco Use Treatment Service and Varenicline Management 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.

Also known as: TUTS + VM, TUT Service + VM

Tobacco Use Treatment Service + Varenicline Management

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently in active practice within Medical and Radiation Oncology divisions of ACC,
• Prescribing authority in Pennsylvania (i.e. physician, nurse practitioner, physician assistant),
• Nonsmoker,
• Has cared for at least one patient with tobacco use disorder in the 30 days prior to recruitment,
• English speaking, and
• Willing to provide informed consent to participate.

You may not qualify if:

• Unwillingness to prescribe varenicline, or
• Unwillingness to assign varenicline management to TUT Service providers.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Schnoll R, Blumenthal D, Wileyto EP, Bauer AM, Evers-Casey S, Stevens N, Fisher T, Ware S, Jenssen BP, Wollack C, Schwartz S, Leone FT. Pilot Trial of a Behavioral Economics-Informed Clinical Decision Support Alert to Improve Inpatient Tobacco Use Treatment Rates. Nicotine Tob Res. 2025 Nov 23;27(12):2265-2272. doi: 10.1093/ntr/ntaf129.

  PMID: 40570180 DERIVED

MeSH Terms

Conditions

Neoplasms; Tobacco Use; Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Robert Schnoll, PhD
• Organization: University of Pennsylvania

schnoll@pennmedicine.upenn.edu

215-746-7143

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 4, 2021
• Study Start: June 28, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 24, 2024
• Last Updated: May 8, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)