Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

N/ARecruitingNCT06851936

University of Florida204 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Nicotine Use Tobacco Use

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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: Baseline

Secondary Outcomes

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: Baseline

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 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

Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic

Time frame: 18 months

Healthcare provider-level adoption of the study intervention

Determine the healthcare provider-level adoption of the study intervention, which is defined as the proportion of eligible healthcare providers participating in the healthcare provider training for this study.

Time frame: 1-2 weeks

Participant satisfaction

Determine participant satisfaction with the nicotine cessation program used in this study, which will be measured using a 4-point Lickert scale.

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

Determine participant adherence to the nicotine cessation program used in this study, as measured by the number of sessions completed (out of 4).

Time frame: 8 weeks after baseline assessment

Participant perspectives on program feasibility and acceptability

Assess participant perspectives on program feasibility and acceptability, using qualitative interviews.

Time frame: Up to 4 weeks after program completion

Healthcare provider perspectives on intervention feasibility and acceptability

Assess healthcare provider perspectives on intervention feasibility and acceptability, using qualitative interviews.