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Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04737031
Acronym
SPP1
Enrollment
2146
Registered
2021-02-03
Start date
2021-05-18
Completion date
2022-07-31
Last updated
2024-02-13

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 main purpose of this research study is to evaluate the effectiveness of nudges to clinicians, to patients, or to both in increasing Tobacco Use Treatment Service (TUTS) referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms. The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing TUTS referral and engagement in cancer patients who smoke, vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

Detailed description

Continued tobacco smoking negatively impacts survival among patients with cancer. Routinely delivered evidence-based tobacco use treatment (TUT) would minimize cancer-specific and all-cause mortality, reduce treatment-related toxicity, and improve quality of life. About 50% of cancer patients who smoked prior to their diagnosis continue to smoke after diagnosis and during treatment. The National Comprehensive Cancer Network, American Society of Clinical Oncology, and American Association for Cancer Research, call for implementation of TUT within oncology care. In 2015, TUT received an A recommendation from the US Preventive Services Task Force, given the high level of certainty of resulting benefit. The approval specifically focused on clinicians asking all adults about smoking, prescribing FDA-approved cessation medications for smokers, and offering appropriate behavioral interventions. Despite the importance of TUT, only half of cancer centers consistently identify patient tobacco use, and few cancer centers employ systematic mechanisms to refer patients to evidence-based cessation services. Acknowledging this gap, the National Cancer Institute (NCI) launched the Cancer Center Cessation Initiative (C3I) as part of the Moonshot to help centers develop effective ways to identify and engage patients who smoke. Penn ISC3 MPI Dr. Schnoll was a member of the NCI advisory board that developed this initiative, and Penn Medicine's Abramson Cancer Center (ACC) was in the first funded cohort. Because clinician expertise in TUT is a known barrier, the initial strategy used an automatic default electronic medical record (EMR) referral to the ACC Tobacco Use Treatment Service (TUTS). Engagement increased, but clinicians turned off the default 60% of the time, implicating additional important barriers to change. This study aims to produce dramatic change within oncology by refining and testing implementation strategies informed by behavioral economics. The investigators' work has identified specific cognitive biases among clinicians and patients that prevent TUTS referral and engagement, including clinician pessimism regarding the ability to help patients stop using tobacco, misconceptions about patient resistance to treatment, and implicit biases regarding the capacity for patients to volitionally alter the course of illness. These motivators are related to clinician willingness to invest effort in help giving and may prevent acquisition of new knowledge and skills. From the patient perspective, several studies identify unique challenges that individuals with cancer face when engaging in tobacco cessation efforts, including low self-efficacy, low perceived benefits of quitting, and perceived risk of treatment. Thus, this study focuses on addressing these barriers, in a pragmatic and innovative way, to increase TUTS referral and engagement in cancer care. The investigators' objectives are to evaluate the effectiveness of nudges to clinicians, to patients, or to both in increasing in TUTS referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms. The investigators will conduct this study with at least 100 clinicians and at least 900 smokers across Penn Medicine's ACC (the clinician sample size may increase with additional clinicians joining Penn and the patient sample size may be higher given the pragmatic design and delay between determination of eligibility \[i.e., patient smokes\] and nudge delivery at a subsequent visit). They expect the study to yield essential insights into the effectiveness of nudges as an implementation strategy to speed the uptake of high value evidence-based TUT within cancer care, and to advance the understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how cancer care settings can ensure that patients with cancer who smoke are engaged with evidence-based TUT and may lead to a future R01 focused on scaling-up this approach across other cancer centers involved in the C3I.

Interventions

Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently fires a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to acknowledge or opt-out when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.

Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
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

Clinician participants must meet the following criteria for inclusion: 1. Currently in practice at an Implementation Lab site (UPHS) 2. Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant) 3. Cared for at least 1 tobacco-using patient in 30 days prior to recruitment 4. English-speaking (messages will be in English) Patient participants must be diagnosed with cancer and report current tobacco smoking (as assessed by an by any staff collecting vital signs or initially rooming the patients such as nurses, front desk staff, MAs, nursing assistants or technicians during an Index Visit). Patients are considered in the analyzable dataset after their Index Visit and after they have a clinic visit with a clinician in the study at which point a nudge may have been delivered (see steps below). The process by which patients become eligible for inclusion involves a 3-step algorithm employed in the EMR: Step 1 - All patients seeking care within the participating Abramson Cancer Center programs are screened for tobacco use status in order to ascertain relevance to the project (i.e., tobacco exposure). This screening encounter need not be a visit with a clinician who is in the cluster randomization. Step 2 - This step occurs at the first visit with a clinician within the cluster randomization. Note that this might be the same encounter in which screening occurs, but does not have to be. At this visit, all patients identified as current smokers are assigned a hidden (i.e., system) variable, the value of which is based on the clinician they are scheduled to meet during that visit (i.e., cluster membership). Step 3 - The logic is engaged at the next (third in series) visit, wherein the system variable is used to guide the intervention based on the clinician's cohort. There must be this visit to permit the delivery of the nudges (or not, if in usual care arm). The primary outcome is clinician referral for tobacco cessation through the EHR at this visit. Thus, patients eligible for this study are only those who are screened (and positive for tobacco use) and have completed the two visits in their randomly assigned cluster (clinician clusters are the unit of randomization) during the study period. Outcomes are assessed at the patient level.

Design outcomes

Primary

MeasureTime frameDescription
Penetration (Rate of Referral to TUTS or Medication Prescription)through study completion, up to one yearDefined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion) Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Secondary

MeasureTime frameDescription
Treatment Engagement Rates (Medication)Up to 30 days following baselineDefined as the number of patients who make a pharmacologically-assisted quit attempt using any of the seven pharmacotherapies within 30 days of the initial oncology visit, divided by the total number of referred patients
Treatment Engagement Rate (Behavioral)Up to 90 days after Repeat VisitDefined as the number of patients who receive a quit-line referral or in-person or telephone cessation counseling, divided by the total number of TUTS-engaged patients
Quit Attempt RateUp to 90 days after Repeat VisitDefined as the number of TUTS-referred patients who make any quit attempt, divided by the total number of TUTS-referred patients
Abstinence RateUp to 90 days after Repeat VisitDefined as the total number of TUTS-referred patients self-reporting 7-day point prevalence abstinence at a 90-day follow-up assessment, divided by the total number of TUTS-referred patients

Countries

United States

Participant flow

Pre-assignment details

2,146 patients were enrolled in this trial. They were seen by a total of 246 clinicians across 88 clusters. Outcome measures were collected for patients.

Participants by arm

ArmCount
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice.
490
Clinician Nudge
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently fires a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to acknowledge or opt-out when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
506
Patient Nudge
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
405
Clinician and Patient Nudge
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently fires a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to acknowledge or opt-out when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
745
Total2,146

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyPatients who did not have a treatment visit03193227

Baseline characteristics

CharacteristicTotalClinician and Patient NudgePatient NudgeUsual CareClinician Nudge
Age, Continuous61.5 years
STANDARD_DEVIATION 12.5
60.7 years
STANDARD_DEVIATION 12.6
62.8 years
STANDARD_DEVIATION 11.7
61.9 years
STANDARD_DEVIATION 12.7
61.2 years
STANDARD_DEVIATION 12.6
Clinician Specialty (seen by patients)
Gynecologic oncology
40 Participants0 Participants11 Participants8 Participants21 Participants
Clinician Specialty (seen by patients)
Hematologic oncology
1752 Participants604 Participants358 Participants388 Participants402 Participants
Clinician Specialty (seen by patients)
Radiology oncology
354 Participants141 Participants36 Participants94 Participants83 Participants
Clinician Type (seen by patients)
Advanced Practice Provider (APP)
542 Participants136 Participants140 Participants130 Participants136 Participants
Clinician Type (seen by patients)
Physician
1604 Participants609 Participants265 Participants360 Participants370 Participants
Days between arm assignment and engagement70.10 days
STANDARD_DEVIATION 71.4
72.00 days
STANDARD_DEVIATION 71.7
64.84 days
STANDARD_DEVIATION 66.4
68.16 days
STANDARD_DEVIATION 69.9
73.42 days
STANDARD_DEVIATION 76.1
Ethnicity (NIH/OMB)
Hispanic or Latino
45 Participants26 Participants5 Participants4 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2100 Participants718 Participants400 Participants486 Participants496 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants0 Participants
Marital Status
Other
1023 Participants313 Participants206 Participants242 Participants262 Participants
Marital Status
Single
1123 Participants432 Participants199 Participants248 Participants244 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants0 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
29 Participants12 Participants3 Participants6 Participants8 Participants
Race (NIH/OMB)
Black or African American
551 Participants200 Participants86 Participants114 Participants151 Participants
Race (NIH/OMB)
More than one race
16 Participants5 Participants5 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants0 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
123 Participants40 Participants27 Participants31 Participants25 Participants
Race (NIH/OMB)
White
1422 Participants488 Participants283 Participants333 Participants318 Participants
Region of Enrollment
United States
2146 participants745 participants405 participants490 participants506 participants
Sex: Female, Male
Female
1003 Participants327 Participants164 Participants238 Participants274 Participants
Sex: Female, Male
Male
1143 Participants418 Participants241 Participants252 Participants232 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 4901 / 5065 / 40518 / 745
other
Total, other adverse events
0 / 4900 / 5060 / 4050 / 745
serious
Total, serious adverse events
0 / 4900 / 5060 / 4050 / 745

Outcome results

Primary

Penetration (Rate of Referral to TUTS or Medication Prescription)

Defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion) Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Time frame: through study completion, up to one year

Population: Outcome measures were not collected for clinicians.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CarePenetration (Rate of Referral to TUTS or Medication Prescription)66 Participants
Clinician NudgePenetration (Rate of Referral to TUTS or Medication Prescription)180 Participants
Patient NudgePenetration (Rate of Referral to TUTS or Medication Prescription)40 Participants
Clinician and Patient NudgePenetration (Rate of Referral to TUTS or Medication Prescription)222 Participants
Secondary

Abstinence Rate

Defined as the total number of TUTS-referred patients self-reporting 7-day point prevalence abstinence at a 90-day follow-up assessment, divided by the total number of TUTS-referred patients

Time frame: Up to 90 days after Repeat Visit

Population: This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareAbstinence Rate0 Participants
Clinician NudgeAbstinence Rate2 Participants
Patient NudgeAbstinence Rate0 Participants
Clinician and Patient NudgeAbstinence Rate1 Participants
Secondary

Quit Attempt Rate

Defined as the number of TUTS-referred patients who make any quit attempt, divided by the total number of TUTS-referred patients

Time frame: Up to 90 days after Repeat Visit

Population: This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareQuit Attempt Rate0 Participants
Clinician NudgeQuit Attempt Rate14 Participants
Patient NudgeQuit Attempt Rate0 Participants
Clinician and Patient NudgeQuit Attempt Rate18 Participants
Secondary

Treatment Engagement Rate (Behavioral)

Defined as the number of patients who receive a quit-line referral or in-person or telephone cessation counseling, divided by the total number of TUTS-engaged patients

Time frame: Up to 90 days after Repeat Visit

Population: This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareTreatment Engagement Rate (Behavioral)0 Participants
Clinician NudgeTreatment Engagement Rate (Behavioral)131 Participants
Patient NudgeTreatment Engagement Rate (Behavioral)0 Participants
Clinician and Patient NudgeTreatment Engagement Rate (Behavioral)133 Participants
Secondary

Treatment Engagement Rates (Medication)

Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of the seven pharmacotherapies within 30 days of the initial oncology visit, divided by the total number of referred patients

Time frame: Up to 30 days following baseline

Population: This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareTreatment Engagement Rates (Medication)52 Participants
Clinician NudgeTreatment Engagement Rates (Medication)66 Participants
Patient NudgeTreatment Engagement Rates (Medication)28 Participants
Clinician and Patient NudgeTreatment Engagement Rates (Medication)88 Participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026