Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
- Conditions
- Lung Non-Small Cell CarcinomaStage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IA1 Lung Cancer AJCC v8Head and Neck Squamous Cell CarcinomaStage IB Lung Cancer AJCC v8Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8
- Interventions
- Other: Best PracticeOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT05412875
- Brief Summary
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.
- Detailed Description
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.
ARM II: Patients receive usual care.
After completion of study intervention, patients are followed up at 2 and 6 months.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (JUUL) Nicotine Replacement 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. Arm I (JUUL) Quality-of-Life Assessment 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. Arm I (JUUL) Questionnaire Administration 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. Arm II (usual care) Best Practice Patients receive usual care. Arm II (usual care) Quality-of-Life Assessment Patients receive usual care. Arm II (usual care) Questionnaire Administration Patients receive usual care.
- Primary Outcome Measures
Name Time Method Feasibility of patients measured by number of screened per month 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 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 Up to 6 months Will be measured by the number of screened patients per month by refusal status.
Reasons for participant ineligibility Baseline We will record reasons for patient ineligibility
Reasons for participant refusal Baseline We will record reasons for patient refusal to participate
Acceptance measured by participation rate Up to 6 months Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Compliance Up to 6 months Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Adherence 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) 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) 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 Up to 6 months Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Quality of life (QOL) - anxiety & depression 2 Up to 6 months Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
Quality of life (QOL) - Perceptions of cancer 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 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 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 Up to 6 months 7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States