CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Nicotine Replacement Therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03482583
NCT03482583Phase 4Completed

Implementation Strategies to Improve Tobacco Treatment for UF Health Cancer Center Patients

University of Florida·interventional·Posted Mar 29, 2018·Updated May 22, 2020

In Brief

A Phase 4 clinical trial evaluating Nicotine Replacement Therapy and Referral to AHEC/Quitline for Smoking, Cigarette. Completed, enrolled 90 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMar 29, 2018
Enrollment StartMay 14, 2018
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago

Interventions

Nicotine Replacement Therapydrug

Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.

Referral to AHEC/Quitlineother

Participants will be referred to local AHEC/Quitline for treatment