Phase 4
N=90
Tobacco Use Treatment in Cancer Patients
Smoking, Cigarette
Bottom Line
View on ClinicalTrials.gov: NCT03482583 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Smoking 7-Day Point Prevalence at 12 Weeks — 2; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine Replacement Therapy (Drug); Referral to AHEC/Quitline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking 7-Day Point Prevalence at 12 Weeks |
2; 2; 3 | — |
| PRIMARY Reach |
90 | — |
| PRIMARY Treatment Utilization |
7; 3; 9 | — |
| PRIMARY Mean Treatment Acceptability Score |
8.1; 5.7; 5.9 | — |
| SECONDARY Change in Cigarettes Smoked Per Day |
-4.7; -12.3; -5.0 | — |
Summary
Tobacco use among cancer survivors reduces the effectiveness of cancer treatments, increases the risk for additional primary cancers, and increases mortality. Implementation of tobacco treatment for cancer patients is challenging, but may be improved substantially with clinically-efficient and sustainable solutions to accurately identify tobacco users, direct them to evidence-based treatment, and provide demonstrable outcomes for stakeholders.
At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment are sub optimal. Further, UFHCC has a largely rural catchment area with a high burden of tobacco-related disease and mortality. To address this research-to-practice gap using a mixed-methods approach to assess the relevant contextual factors at UFHCC and evaluate the feasibility of implementing a multi-level intervention to increase tobacco treatment utilization and improve health outcomes.
This study uses a mixed methods approach and will inform the design of a pragmatic clinical trial to improve the delivery of tobacco use treatment services to cancer patients. Guided by a conceptual model that emphasizes patient, provider, and organizational characteristics, the study team will identify factors that influence the implementation process at the UFHCC. The ultimate goal of the proposed research is to provide new knowledge to facilitate the widespread adoption, implementation, and dissemination and sustained utilization of evidence-based tobacco use treatments in cancer care settings.
Eligibility Criteria
Inclusion Criteria
- UF Health cancer patients, 18 years and older, who are current smokers.
Exclusion Criteria
- Patients with unstable medical or psychiatric illness or
- Patients with a use disorder for illicit drugs.
Data sourced from ClinicalTrials.gov (NCT03482583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.