A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of patients measured by number of screened per month
研究概览
简要总结
This clinical trial investigates the acceptability of electronic cigarettes (JUUL) for smoking cessation (quitting smoking) and the reduction of surgery-related complications in patients with newly diagnosed head, neck, or lung cancer. Smoking before surgery is associated with increased risk of complications during and after surgery. Electronic cigarettes are a type of special product that gives small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Stopping cigarette smoking before surgery may reduce the risk of complications during and after surgery in patients with head, neck, or lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate feasibility, acceptability, compliance, and safety of a non-randomized 2-month trial of a pod based electronic cigarette (intervention) versus usual care for stage I-III lung cancer patients and stage I-IV head and neck cancer patients undergoing surgical resection.
II. Examine the effect of the pod based electronic cigarette (intervention) on surgical complications, quality of life, and whether it promotes complete or incomplete switching to the non-combustible product.
OUTLINE: Patients choose to participate in 1 of 2 arms.
ARM I: Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed lung cancer subjects will be stages I-III non-small cell lung cancer (NSCLC) and head and neck cancer subjects will be stages I-IV squamous cell carcinoma (SCC).
- •Current smokers of combustible cigarettes who smoke >= 4 days/week.
- •Lung cancer patients planning to undergo wedge resection surgery for their index cancer.
- •Head and neck cancer patients planning to undergo surgical resection of their index cancer or exploratory biopsies (tonsil cancer).
- •Patients must intend to receive ongoing oncology care at Ohio State University [OSU] (i.e., their clinic visit is not a consultation/second opinion).
- •Patients that are over the age of 21 years.
排除标准
- •Patients who are cognitively unable to understand the consent form or participate in interviews.
- •Patients with hearing impairments.
- •Patients who are planning to use or are currently using cessation medication to help quit or reduce smoking.
- •Patients who are currently using e-cigarettes.
- •Patients undergoing surgery including lobectomy, pneumonectomy, tracheotomy, laryngectomy, or free flap surgery.
- •Patients with contraindications to per oral intake.
- •Lung cancer patients who are on home supplemental oxygen at baseline.
- •Patients that have problems with dexterity that would impact electronic cigarette use.
- •Patients under 21 years of age.
- •Patients who don't speak and read English.
- •Patients with histologies other than NSCLC, or squamous cell carcinoma of the head and neck.
- •Patients with nasopharyngeal, thyroid, or gland cancers.
- •Patients with inoperable tumors.
- •Pregnant women.
- •Prisoners.
研究组 & 干预措施
Arm I (JUUL)
Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.
干预措施: Nicotine Replacement (Drug)
Arm I (JUUL)
Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.
干预措施: Quality-of-Life Assessment (Other)
Arm I (JUUL)
Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.
干预措施: Questionnaire Administration (Other)
Arm II (usual care)
Patients receive usual care.
干预措施: Best Practice (Other)
Arm II (usual care)
Patients receive usual care.
干预措施: Quality-of-Life Assessment (Other)
Arm II (usual care)
Patients receive usual care.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Feasibility of patients measured by number of screened per month
时间窗: Up to 6 months
Will be measured by the number of screened patients per month.
Feasibility of patients measured by number of screened per month by eligibility status
时间窗: Up to 6 months
Will be measured by the number of screened patients per month by eligibility status.
Feasibility of patients measured by number of screened per month by refusal status
时间窗: Up to 6 months
Will be measured by the number of screened patients per month by refusal status.
Reasons for participant ineligibility
时间窗: Baseline
We will record reasons for patient ineligibility
Reasons for participant refusal
时间窗: Baseline
We will record reasons for patient refusal to participate
Acceptance measured by participation rate
时间窗: Up to 6 months
Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Compliance
时间窗: Up to 6 months
Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Adherence
时间窗: Baseline and hospital admission for surgery
Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.
Incidence of adverse events (AEs)
时间窗: Up to 14 days after delivery of intervention
Will be assessed at days 2 and 14 following the delivery of the intervention and reported by participants. Further, participants will be invited to contact the research team to report any adverse events related to the use of the intervention at any time point.
Complication rate (primary preliminary efficacy)
时间窗: Up to 6 months
Will be measured as the number of complications reported, per person month of follow up.
Quality of life (QOL) - anxiety & depression
时间窗: Up to 6 months
Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Quality of life (QOL) - anxiety & depression 2
时间窗: Up to 6 months
Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
Quality of life (QOL) - Perceptions of cancer
时间窗: Up to 6 months
Self-reported QOL measures will include the Perceptions of Lung Cancer to assess views on their disease (modified slightly for head and neck cancer patients)
Quality of life (QOL) - Health outcomes
时间窗: Up to 6 months
Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).
Quality of life (QOL) - Health outcomes 2
时间窗: Up to 6 months
Self-reported QOL measures will include the and EORTC-QLQ-LC13 to assess overall and cancer-specific health outcomes (including cough, dyspnes, dysphagia, and pain).
7 day point prevalence of tobacco use
时间窗: Up to 6 months
7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups
次要结局
未报告次要终点
研究者
Theodore Brasky PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center