Clinical trial NCT06851936: Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Official title: Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nicotine Use
Tobacco Use
Keywords: tobacco cessation
AHEC
cancer survivors
tobacco
nicotine
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Program reach for cancer survivors
timeFrame: Baseline
Secondary outcomes:
measure: Program reach for caregivers/family members of cancer survivors
timeFrame: Baseline
measure: Program effectiveness in tobacco cessation
timeFrame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
measure: Program effectiveness in tobacco cessation
timeFrame: Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions
measure: Clinic-level adoption of the study intervention
timeFrame: 18 months
measure: Healthcare provider-level adoption of the study intervention
timeFrame: 1-2 weeks
measure: Participant satisfaction
timeFrame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
measure: Participant adherence
timeFrame: 8 weeks after baseline assessment
measure: Participant perspectives on program feasibility and acceptability
timeFrame: Up to 4 weeks after program completion
measure: Healthcare provider perspectives on intervention feasibility and acceptability
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Jennifer LeLaurin, PhD
role: PRINCIPAL_INVESTIGATOR
References: