Clinical trial · Interventional
Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Nicotine Dependence | — | UNRESOLVED | — |
| Smoking | — | UNRESOLVED | — |
| Tobacco Use | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinician Nudge | Other | — | UNRESOLVED |
| Patient Nudge | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Clinicians and patients will receive no further interventions beyond usual practice.
- type
- EXPERIMENTAL
- label
- Clinician Nudge
- description
- Clinicians will receive a nudge via Best Practice Alert within the EMR
- interventionNames
- Other: Clinician Nudge
- type
- EXPERIMENTAL
- label
- Patient Nudge
- description
- Patients will receive a message sent through myPennMedicine following establishment of their smoking status.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDJenssen BP, Schnoll R, Beidas RS, Bekelman J, Bauer AM, Evers-Casey S, Fisher T, Scott C, Nicoloso J, Gabriel P, Asch DA, Buttenheim AM, Chen J, Melo J, Grant D, Horst M, Oyer R, Shulman LN, Clifton ABW, Lieberman A, Salam T, Rendle KA, Chaiyachati KH, Shelton RC, Fayanju O, Wileyto EP, Ware S, Blumenthal D, Ragusano D, Leone FT. Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke. J Clin Oncol. 2023 Oct 1;41(28):4511-4521. doi: 10.1200/JCO.23.00355. Epub 2023 Jul 19. PMID 37467454
- DERIVEDJenssen BP, Schnoll R, Beidas R, Bekelman J, Bauer AM, Scott C, Evers-Casey S, Nicoloso J, Gabriel P, Asch DA, Buttenheim A, Chen J, Melo J, Shulman LN, Clifton ABW, Lieberman A, Salam T, Zentgraf K, Rendle KA, Chaiyachati K, Shelton R, Wileyto EP, Ware S, Leone F. Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke. Implement Sci. 2021 Jul 15;16(1):72. doi: 10.1186/s13012-021-01139-7. PMID 34266468