NCT03482583

Tobacco Use Treatment in Cancer Patients

Completed Phase 4 Results posted Last updated 22 May 2020

What this trial tests

Phase 4 trial testing Nicotine Replacement Therapy in Smoking, Cigarette in 90 participants. Completed in 31 December 2019.

Timeline

14 May 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of Florida
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	14 May 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	5 locations across United States

Drugs / interventions tested

• Nicotine Replacement Therapy — full drug profile →
• Referral to AHEC/Quitline

Conditions studied

• Smoking, Cigarette — all drugs for Smoking, Cigarette →

Sponsor

University of Florida

Who can join

18 and older, any sex, with Smoking, Cigarette. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Smoking 7-Day Point Prevalence at 12 Weeks Primary · 12 weeks

Using intent-to-treat analysis, 3 (7.7%) PhoneQuit, 2 (5.4%) SmartQuit, and 2 (14.3%) GroupQuit patients reported 7-day point prevalence abstinence from smoking. Smart Quit abstinence was verified with CO readings.

Group	Value	95% CI
Cognitive Behavior Therapy With NRT	2
Referral to Area Health Education Center	2
Referral to Qutiline	3

Reach Primary · 12 weeks

Number of smokers visiting the clinics who are enrolled divided by the total number of smokers visiting the clinics.

Group	Value	95% CI
Eligible Patients	90

Treatment Utilization Primary · 12 weeks

Percent of enrolled patient who completed any tobacco-use treatment.

Group	Value	95% CI
Cognitive Behavior Therapy With NRT	7
Referral to Area Health Education Center	3
Referral to Qutiline	9

Mean Treatment Acceptability Score Primary · 12 weeks

Treatment Acceptability (TAQ) consisted of 16 items scored on a 0 to 10 scale (0=worst, 10=best). The questions assessed aspects of treatment acceptability, such as helpfulness in reducing smoking and thoughts and feelings related to the treatment. Data represents the mean score across all items (range 0-10).

Group	Value	95% CI
Cognitive Behavior Therapy With NRT	8.1	± 1.2
Referral to Area Health Education Center	5.7	± 3.5
Referral to Qutiline	5.9	± 1.8

Change in Cigarettes Smoked Per Day Secondary · Baseline to 12 weeks

Change in Mean Cigarettes Smoked Per Day

Group	Value	95% CI
Cognitive Behavior Therapy With NRT	-4.7	± 13.7
Referral to Area Health Education Center	-12.3	± 7.5
Referral to Qutiline	-5.0	± 6.3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An Implementation Trial to Improve Tobacco Treatment for Cancer Patients: Patient Preferences, Treatment Acceptability and Effectiveness.
   LeLaurin JH, Dallery J, Silver NL, Markham MJ, et al · · 2020 · cited 11× · PMID 32231062 · DOI 10.3390/ijerph17072280