Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training.
Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
Any history of cancer diagnosis. Subjects currently receiving cancer-related treatments are eligible for enrollment.
Receiving care from the participating UF Health clinics (Medical Oncology, Urology, and Radiation Oncology).
Capable of completing study requirements
Disqualifiers
Patients unable to complete the sessions because of language, travel or technology barriers
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Participants unable to complete the sessions because of language, travel or technology barriers
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Trial design
Design model
Single group
Treatments tested in this trial
Nicotine cessation program
BehavioralAll participants will complete a nicotine cessation program designed by Area Health Education Center (AHEC). The focus is on known tobacco cessation techniques and motivations to quit with additional focuses on cancer survivors and caregivers. The program consists of 4 sessions (each session is approximately 60 minutes long) that will be delivered by a Tobacco Treatment Specialist by either videoconference or by telephone. Dyad enrollees (i.e., cancer survivors and their caregiver/family member) will complete sessions together. Participants will also be eligible for free nicotine replacement therapy while on study if medically appropriate.
Treatment groups
204 Participants
are divided into 1 treatment groupGroup A: Nicotine Cessation ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Program reach for cancer survivors
Determine the reach of the nicotine cessation program used in this study for cancer survivors. This is defined as the proportion of eligible patients enrolled (i.e., agreed to participate and consented) during the study period.
Time frame
BaselineSecondary outcomes
1
Program reach for caregivers/family members of cancer survivors
Determine the reach of the nicotine cessation program used in this study for caregivers/family members of cancer survivors. This is defined as the proportion of enrolled cancer survivors who also have a family member/caregiver enrolled.
Time frame
Baseline2
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Time frame
Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions3
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Time frame
Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions4
Clinic-level adoption of the study intervention
Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov