Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started May 2018

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

March 23, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed

5 months until next milestone

Results Posted

Study results publicly available

May 22, 2020

Completed

Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

March 23, 2018

Results QC Date

February 11, 2020

Last Update Submit

May 7, 2020

Conditions

Smoking, Cigarette

Keywords

Smoking, Cancer, Treatment

Outcome Measures

Primary Outcomes (4)

Smoking 7-Day Point Prevalence at 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.
12 weeks
Reach
Number of smokers visiting the clinics who are enrolled divided by the total number of smokers visiting the clinics.
12 weeks
Treatment Utilization
Percent of enrolled patient who completed any tobacco-use treatment.
12 weeks
Mean Treatment Acceptability Score
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).
12 weeks

Secondary Outcomes (1)

Change in Cigarettes Smoked Per Day
Baseline to 12 weeks

Study Arms (3)

Cognitive Behavior Therapy with NRT

OTHER

Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.

Drug: Nicotine Replacement Therapy

Referral to Area Health Education Center

OTHER

The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.

Other: Referral to AHEC/Quitline

Referral to Qutiline

OTHER

Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use. The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.

Other: Referral to AHEC/Quitline

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.

Also known as: Nicotine Patch

Cognitive Behavior Therapy with NRT

Referral to AHEC/QuitlineOTHER

Participants will be referred to local AHEC/Quitline for treatment

Referral to Area Health Education CenterReferral to Qutiline

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

UF Health cancer patients, 18 years and older, who are current smokers.

You may not qualify if:

Patients with unstable medical or psychiatric illness or
Patients with a use disorder for illicit drugs.

Contact the study team to confirm eligibility.