Tobacco Use Treatment in Cancer Patients

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.

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.