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Tobacco Use Treatment in Cancer Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03482583
Enrollment
90
Registered
2018-03-29
Start date
2018-05-14
Completion date
2019-12-31
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Cigarette

Keywords

Smoking, Cancer, 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.

Interventions

DRUGNicotine 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.

OTHERReferral to AHEC/Quitline

Participants will be referred to local AHEC/Quitline for treatment

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Smoking 7-Day Point Prevalence at 12 Weeks12 weeksUsing 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.
Reach12 weeksNumber of smokers visiting the clinics who are enrolled divided by the total number of smokers visiting the clinics.
Treatment Utilization12 weeksPercent of enrolled patient who completed any tobacco-use treatment.
Mean Treatment Acceptability Score12 weeksTreatment 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).

Secondary

MeasureTime frameDescription
Change in Cigarettes Smoked Per DayBaseline to 12 weeksChange in Mean Cigarettes Smoked Per Day

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
37
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. Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
14
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. Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
39
Total90

Baseline characteristics

CharacteristicTotalCognitive Behavior Therapy With NRTReferral to QutilineReferral to Area Health Education Center
Age, Continuous58.0 years
STANDARD_DEVIATION 10.2
55.5 years
STANDARD_DEVIATION 13.1
60.6 years
STANDARD_DEVIATION 1.2
57.3 years
STANDARD_DEVIATION 6.9
Age of Smoking Initiation17.0 years
STANDARD_DEVIATION 8
16.2 years
STANDARD_DEVIATION 6.4
18.9 years
STANDARD_DEVIATION 6.2
21.0 years
STANDARD_DEVIATION 8.1
Cancer Diagnosis
Over 12 Months
38 Participants16 Participants17 Participants5 Participants
Cancer Diagnosis
Past 1-3 Months
14 Participants4 Participants7 Participants3 Participants
Cancer Diagnosis
Past 4-6 Months
17 Participants7 Participants7 Participants3 Participants
Cancer Diagnosis
Past 7-12 Months
7 Participants3 Participants2 Participants2 Participants
Cancer Diagnosis
Past Month
9 Participants5 Participants4 Participants0 Participants
Cancer Diagnosis
Past Week
5 Participants2 Participants2 Participants1 Participants
Cancer Site
Bone
9 Participants3 Participants4 Participants2 Participants
Cancer Site
Brain
7 Participants1 Participants4 Participants2 Participants
Cancer Site
Breast
13 Participants7 Participants6 Participants0 Participants
Cancer Site
Gastrointestinal
21 Participants5 Participants11 Participants5 Participants
Cancer Site
Genitourinary
12 Participants3 Participants7 Participants2 Participants
Cancer Site
Gynecologic
5 Participants2 Participants1 Participants2 Participants
Cancer Site
Head and Neck
33 Participants20 Participants8 Participants5 Participants
Cancer Site
Hematologic/Blood
11 Participants4 Participants3 Participants4 Participants
Cancer Site
Lung
26 Participants11 Participants11 Participants4 Participants
Cancer Site
Other
5 Participants1 Participants3 Participants1 Participants
Cancer Site
Thyroid
2 Participants0 Participants2 Participants0 Participants
Cigarettes/Day14.2 Cigarettes/day
STANDARD_DEVIATION 11.5
13.8 Cigarettes/day
STANDARD_DEVIATION 12.1
12.3 Cigarettes/day
STANDARD_DEVIATION 8.5
20.1 Cigarettes/day
STANDARD_DEVIATION 15.1
Cigarette Smoking Frequency
Declined to answer
3 Participants0 Participants2 Participants1 Participants
Cigarette Smoking Frequency
Every Day
77 Participants34 Participants30 Participants13 Participants
Cigarette Smoking Frequency
Some Days
10 Participants3 Participants7 Participants0 Participants
E-Cigarette Use Frequency
Declined to Answer
2 Participants0 Participants1 Participants1 Participants
E-Cigarette Use Frequency
Every Day
6 Participants4 Participants1 Participants1 Participants
E-Cigarette Use Frequency
Not at All
65 Participants27 Participants27 Participants11 Participants
E-Cigarette Use Frequency
Some Days
17 Participants6 Participants10 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
88 Participants36 Participants39 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Patient Exit Interview (PEI)7.4 units on a scale
STANDARD_DEVIATION 2.7
7.7 units on a scale
STANDARD_DEVIATION 2.6
7.2 units on a scale
STANDARD_DEVIATION 2.9
6.9 units on a scale
STANDARD_DEVIATION 2.9
Race/Ethnicity, Customized
Black/African American
17 Participants5 Participants8 Participants4 Participants
Race/Ethnicity, Customized
Other
9 Participants4 Participants2 Participants3 Participants
Race/Ethnicity, Customized
White
68 Participants29 Participants30 Participants9 Participants
Region of Enrollment
United States
90 Participants37 Participants39 Participants14 Participants
Rurality
Rural
28 Participants11 Participants11 Participants6 Participants
Rurality
Urban
62 Participants26 Participants28 Participants8 Participants
Sex: Female, Male
Female
50 Participants21 Participants19 Participants10 Participants
Sex: Female, Male
Male
40 Participants16 Participants20 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 140 / 39
other
Total, other adverse events
0 / 370 / 140 / 39
serious
Total, serious adverse events
0 / 370 / 140 / 39

Outcome results

Primary

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).

Time frame: 12 weeks

Population: Participants who completed tobacco-use treatment

ArmMeasureValue (MEAN)Dispersion
Cognitive Behavior Therapy With NRTMean Treatment Acceptability Score8.1 score on a scaleStandard Deviation 1.2
Referral to Area Health Education CenterMean Treatment Acceptability Score5.7 score on a scaleStandard Deviation 3.5
Referral to QutilineMean Treatment Acceptability Score5.9 score on a scaleStandard Deviation 1.8
Primary

Reach

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

Time frame: 12 weeks

Population: Smokers visiting the clinic during the study period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cognitive Behavior Therapy With NRTReach90 Participants
Primary

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.

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cognitive Behavior Therapy With NRTSmoking 7-Day Point Prevalence at 12 Weeks2 Participants
Referral to Area Health Education CenterSmoking 7-Day Point Prevalence at 12 Weeks2 Participants
Referral to QutilineSmoking 7-Day Point Prevalence at 12 Weeks3 Participants
Primary

Treatment Utilization

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

Time frame: 12 weeks

Population: Participants that completed follow up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cognitive Behavior Therapy With NRTTreatment Utilization7 Participants
Referral to Area Health Education CenterTreatment Utilization3 Participants
Referral to QutilineTreatment Utilization9 Participants
Secondary

Change in Cigarettes Smoked Per Day

Change in Mean Cigarettes Smoked Per Day

Time frame: Baseline to 12 weeks

Population: Participants completing 12 week follow up.

ArmMeasureValue (MEAN)Dispersion
Cognitive Behavior Therapy With NRTChange in Cigarettes Smoked Per Day-4.7 cigarettes smoked per dayStandard Deviation 13.7
Referral to Area Health Education CenterChange in Cigarettes Smoked Per Day-12.3 cigarettes smoked per dayStandard Deviation 7.5
Referral to QutilineChange in Cigarettes Smoked Per Day-5.0 cigarettes smoked per dayStandard Deviation 6.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026