Tobacco Use Treatment in Cancer Patients

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

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 Overview

• Status: Completed
• Conditions: Smoking, Cigarette
• Intervention / Treatment: Drug: Nicotine Replacement Therapy; Other: Referral to AHEC/Quitline

Detailed Description

Study Design: 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.

Study Setting: The pilot study will be conducted at the UF Health Medical Oncology and Ear, Nose & Throat (ENT) clinics. Smoking is the leading cause of head and neck cancers, and almost one-third of patients continue to smoke after their head and neck cancer diagnosis, making this a priority population for intervention.

Population: UF Health cancer patients ≥18 yrs old who are current smokers and smartphone users; for mCBT, the investigators will also ensure CO breath sample >5 parts per million (ppm). Patients with unstable medical or psychiatric illness or use disorder for illicit drugs will be excluded.

Procedures: The investigators will request Epic access to identify potential subjects and schedule recruitment during clinic hours. Research assistants (RAs) will be at the Medical Oncology and ENT clinics to meet with eligible patients during their visit. RAs will approach eligible patients at checkout after they are introduced by someone who has a clinical relationship with the patient. Following screening and brief counseling by the provider, RAs will offer eligible patients the 3 TUT options (i.e., AHEC, Quitline, or mCBT), obtain informed consent using REDCap (eConsent) or a paper consent (if desired by the patient), administer the Patient Exit Interview (PEI) in REDCap, and arrange a follow-up phone interview. Patients who choose AHEC/Quitline will be referred by a nurse using Epic. Those choosing mCBT will be trained on the use of Vidyo and the iCOTM Smokelyzer® by the RA, and follow-up will be arranged with a CTTS counselor.

Participants in mCBT will meet with a trained certified tobacco treatment counselor on Vidyo for 30 minutes, once a week, for 6 weeks. The counselor will cover topics that include addiction, withdrawal, dealing with triggers, overcoming cravings, and relapse prevention. At enrollment, investigators will offer mCBT participants-if interested-a 2-week supply of nicotine replacement therapy (NRT). The 2-week supply of NRT is consistent with what is offered to participants at AHEC and the Quitline. Participants who smoke less than 10 cigarettes per day will receive 14 mg of NRT, and those who smoke more than 10 cigarettes per day will receive 21 mg of NRT. Medical clearance from the provider will be obtained prior to NRT administration. At the end of the study (week 12), participants (all participants in mCBT and a random sample of patients referred to AHEC/Quitline) will complete the follow-up telephone interview. At the end of the study, participants (AHEC/Quitline & mCBT) may also provide a saliva sample to test their cotinine level; this process will be remotely monitored via Vidyo for participants in mCBT and participants in AHEC/Quitline will be encouraged to contact study staff to answer any questions they may have. Evaluation tools also consist of Patient Exit Interviews and Telephone Survey to be administered among research participants.

Analysis Plan: All data collected will be entered in a REDCap database. The primary analysis will be the estimation of rates/means, with 95% CIs. To demonstrate the feasibility of the 3 implementation strategies, investigators will measure reach as the number of smokers visiting the 2 clinics who are referred to any TUT (i.e., AHEC/Quitline/mCBT) divided by the total number of smokers visiting the clinics. For each TUT, investigators will calculate enrollment as the total number of smokers who enroll in a given treatment divided by the total number of referred smokers; investigators will compare the rates of patients selecting into each of the 3 TUT programs. Investigators will assess TUT completion as the number of enrolled smokers who complete the program. Investigators will also evaluate acceptability using TAQ. As secondary outcomes, investigators will measure prolonged abstinence at week 12 and the change (baseline to week 12) in past-7-day point prevalence (all programs), as well as CO-verified abstinence at weeks 6 &12 (mCBT only). CO levels will also be modeled across time (weeks 1, 6, 12) to assess for reductions over time via linear mixed models.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Gainesville, Florida, United States, 32611
      • UF Ear Nose and Throat (ENT)
    • Gainesville, Florida, United States, 32611
      • UF Health at the University of Florida
    • Gainesville, Florida, United States, 32611
      • UF Health Medical Oncology
    • Gainesville, Florida, United States, 32611
      • UF Health Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cognitive Behavior Therapy with NRT; 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; 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.; Other Names: Nicotine Patch
OTHER: Referral to Area Health Education Center; 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; Participants will be referred to local AHEC/Quitline for treatment
OTHER: Referral to Qutiline; 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; Participants will be referred to local AHEC/Quitline for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cigarettes Smoked Per Day	Change in Mean Cigarettes Smoked Per Day	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Ramzi G. Salloum, PhD, MBA, University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Smoking, Cancer, Treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB201702115 -A; OCR17294 (OTHER: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes