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NCT Number: NCT06851936

Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

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.

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Key information

Conditions

Nicotine Use Behavior Health Behavior Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Erika Barahona, M. Ed

CONTACT

[email protected]

352-273-7345

Jennifer LeLaurin, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine cessation program

Behavioral

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) will complete sessions together. Participants will also be eligible for free nicotine replacement therapy while on study if medically appropriate.

Primary outcomes

  1. Program reach for cancer survivors

    Time frame: Baseline

    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.

Secondary outcomes

  1. Program reach for caregivers/family members of cancer survivors

    Time frame: Baseline

    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.

  2. 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

    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).

  3. 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

    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).

  4. Clinic-level adoption of the study intervention

    Time frame: 18 months

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

  5. Healthcare provider-level adoption of the study intervention

    Time frame: 1-2 weeks

    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.

  6. 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

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

  7. Participant adherence

    Time frame: 8 weeks after baseline assessment

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

  8. Participant perspectives on program feasibility and acceptability

    Time frame: Up to 4 weeks after program completion

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

  9. Healthcare provider perspectives on intervention feasibility and acceptability

    Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Barahona, M. Ed

CONTACT

[email protected]

352-273-7345

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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