Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotine cessation program.
- Who it may be relevant to
- Registry conditions: Nicotine Use, Tobacco Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Nicotine cessation program
All 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)
Primary outcome measures
- Program reach for cancer survivors [Time frame: Baseline]
Secondary outcome measures (9)
- Program reach for caregivers/family members of cancer survivors [Time frame: Baseline]
- Program effectiveness in tobacco cessation [Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions]
- Program effectiveness in tobacco cessation [Time frame: Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions]
- Clinic-level adoption of the study intervention [Time frame: 18 months]
- Healthcare provider-level adoption of the study intervention [Time frame: 1-2 weeks]
- Participant satisfaction [Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions]
- Participant adherence [Time frame: 8 weeks after baseline assessment]
- Participant perspectives on program feasibility and acceptability [Time frame: Up to 4 weeks after program completion]
- Healthcare provider perspectives on intervention feasibility and acceptability [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
Cancer Survivors including Current Cancer Patients
- 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
- Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
- Adults aged ≥18 years
Informal Caregivers/Family Members of Cancer Survivors
- 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.
- A family member, informal caregiver, or friend of an enrolled cancer survivor receiving care from the participating UF Health clinics as described above
- Capable of completing study requirements
- Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
- Adults aged ≥18 years
Exclusion criteria
Cancer Survivors including Current Cancer Patients
- 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.
Informal Caregivers/Family Members of Cancer Survivors
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT06851936 · UF-CCPS-039 · IRB202500401