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Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

NCT04738643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 685

Last updated 2025-05-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-12-31
Completion
2024-01-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738643 on ClinicalTrials.gov