Clinical trial NCT03482583: Tobacco Use Treatment in Cancer Patients
Official title: Implementation Strategies to Improve Tobacco Treatment for UF Health Cancer Center Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking, Cigarette
Keywords: Smoking, Cancer, Treatment
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Smoking 7-Day Point Prevalence at 12 Weeks
timeFrame: 12 weeks
measure: Reach
timeFrame: 12 weeks
measure: Treatment Utilization
timeFrame: 12 weeks
measure: Mean Treatment Acceptability Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Cigarettes Smoked Per Day
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Ear Nose and Throat (ENT)
state: Florida
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Medical Oncology
state: Florida
city: Gainesville
country: United States
facility: UF Health Radiation Oncology
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ramzi G. Salloum, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: