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Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04738643
Enrollment
685
Registered
2021-02-04
Start date
2022-06-28
Completion date
2024-01-24
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Nicotine Dependence, Smoking, Tobacco Use

Keywords

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

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.

Interventions

OTHERTobacco 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

University of Pennsylvania
CollaboratorOTHER
Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention Ordering RateUp to 30 days after Initial VisitDefined 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

Secondary

MeasureTime frameDescription
Outpatient/Discharge Medication Ordering RateUp to 30 days after Initial VisitDefined as the number of patients for whom any tobacco use treatment medication was ordered upon patient discharge from the hospital, divided by the total number of patients in each arm for whom an order was pended and the alert fired
TUTS Referral RateUp to 30 days after Initial VisitDefined as the number of inpatients for whom a referral to the health system's Smoking Cessation Program was placed, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Inpatient Medication Ordering RateUp to 30 days after Initial VisitDefined as the number of patients for whom any inpatient tobacco use treatment medication was ordered, divided by the total number of patients in each arm for whom an order was pended and the alert fired
Medication Recommendation Rate30 Day Follow-up AssessmentDefined as the number of patients who are recommended to receive a tobacco use treatment medication by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling
Follow-up Recommendation Rate30 Day Follow-up AssessmentDefined as the number of patients who are recommended to receive a tobacco use treatment medication or a follow-up appointment by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling
Quit Line Rate30 Day Follow-up AssessmentDefined as the total number of patients who present for quit line counseling (i.e. telephone or electronic), divided by the total number of patients referred to the Smoking Cessation Program

Countries

United States

Participant flow

Pre-assignment details

635 patients accrued to the study, and the 50 clinicians who saw these patients received either the intervention alert or the usual care alert depending on the arm to which they were randomized. In total, this resulted in 685 individuals who were involved in the trial.

Participants by arm

ArmCount
Usual Care
TUT Service Only
397
Tobacco Use Treatment Service + Varenicline Management
TUTS + Varenicline Management 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.
238
Total635

Baseline characteristics

CharacteristicUsual CareTotalTobacco Use Treatment Service + Varenicline Management
Age, Continuous55.66 years
STANDARD_DEVIATION 13.73
56.53 years
STANDARD_DEVIATION 13.87
57.99 years
STANDARD_DEVIATION 14.02
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants14 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
383 Participants614 Participants231 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Black or African American
294 Participants475 Participants181 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
17 Participants28 Participants11 Participants
Race (NIH/OMB)
White
82 Participants125 Participants43 Participants
Region of Enrollment
United States
397 participants635 participants238 participants
Sex: Female, Male
Female
175 Participants272 Participants97 Participants
Sex: Female, Male
Male
222 Participants363 Participants141 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3970 / 238
other
Total, other adverse events
0 / 3970 / 238
serious
Total, serious adverse events
0 / 3970 / 238

Outcome results

Primary

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

Time frame: Up to 30 days after Initial Visit

Population: Outcome measures were only assessed for patients.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareIntervention Ordering Rate113 Participants
Tobacco Use Treatment Service + Varenicline ManagementIntervention Ordering Rate60 Participants
Secondary

Follow-up Recommendation Rate

Defined as the number of patients who are recommended to receive a tobacco use treatment medication or a follow-up appointment by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling

Time frame: 30 Day Follow-up Assessment

Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareFollow-up Recommendation Rate4 Participants
Tobacco Use Treatment Service + Varenicline ManagementFollow-up Recommendation Rate5 Participants
Secondary

Inpatient Medication Ordering Rate

Defined as the number of patients for whom any inpatient tobacco use treatment medication was ordered, divided by the total number of patients in each arm for whom an order was pended and the alert fired

Time frame: Up to 30 days after Initial Visit

Population: Outcomes were only assessed for patients.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareInpatient Medication Ordering Rate73 Participants
Tobacco Use Treatment Service + Varenicline ManagementInpatient Medication Ordering Rate41 Participants
Secondary

Medication Recommendation Rate

Defined as the number of patients who are recommended to receive a tobacco use treatment medication by the TUT Service staff in quit line counseling, divided by the total number of patients who present for quit line counseling

Time frame: 30 Day Follow-up Assessment

Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program and appeared for a consult.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareMedication Recommendation Rate4 Participants
Tobacco Use Treatment Service + Varenicline ManagementMedication Recommendation Rate4 Participants
Secondary

Outpatient/Discharge Medication Ordering Rate

Defined as the number of patients for whom any tobacco use treatment medication was ordered upon patient discharge from the hospital, divided by the total number of patients in each arm for whom an order was pended and the alert fired

Time frame: Up to 30 days after Initial Visit

Population: Outcomes were only assessed for patients.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareOutpatient/Discharge Medication Ordering Rate26 Participants
Tobacco Use Treatment Service + Varenicline ManagementOutpatient/Discharge Medication Ordering Rate17 Participants
Secondary

Quit Line 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 patients referred to the Smoking Cessation Program

Time frame: 30 Day Follow-up Assessment

Population: This outcome was only assessed for patients who were referred to the Smoking Cessation Program.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareQuit Line Rate5 Participants
Tobacco Use Treatment Service + Varenicline ManagementQuit Line Rate5 Participants
Secondary

TUTS Referral Rate

Defined as the number of inpatients for whom a referral to the health system's Smoking Cessation Program was placed, divided by the total number of patients in each arm for whom an order was pended and the alert fired

Time frame: Up to 30 days after Initial Visit

Population: Outcomes were only assessed for patients.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareTUTS Referral Rate13 Participants
Tobacco Use Treatment Service + Varenicline ManagementTUTS Referral Rate20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026