Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

Обзор

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.

Вмешательства

• Поведенческое 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)

Первичные конечные точки

• Program reach for cancer survivors [Срок оценки: Baseline]

Вторичные конечные точки (9)

• Program reach for caregivers/family members of cancer survivors [Срок оценки: Baseline]
• Program effectiveness in tobacco cessation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 18 months]
• Healthcare provider-level adoption of the study intervention [Срок оценки: 1-2 weeks]
• Participant satisfaction [Срок оценки: 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 [Срок оценки: 8 weeks after baseline assessment]
• Participant perspectives on program feasibility and acceptability [Срок оценки: Up to 4 weeks after program completion]
• Healthcare provider perspectives on intervention feasibility and acceptability [Срок оценки: 18 months]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT06851936 · UF-CCPS-039 · IRB202500401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗