Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Squamous Cell

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

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.

Best Practice

Nicotine Replacement

Quality-of-Life Assessment

Questionnaire Administration

Theodore Brasky, PhD

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.

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.

Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung

A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung

Will be measured by the number of screened patients per month.

Will be measured by the number of screened patients per month by eligibility status.

Will be measured by the number of screened patients per month by refusal status.

We will record reasons for patient ineligibility

We will record reasons for patient refusal to participate

Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.

Will be self-reported and include counting of used JUUL pods on follow-ups interviews.

Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.

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.

Will be measured as the number of complications reported, per person month of follow up.

Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)

Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)

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)

Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).

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 (i.e., switching) will be measured at follow-ups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung	NCT05412875	Head and Neck S... Lung Non-Small ... Stage I Cutaneo... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage II Cutane... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Cutan... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Cutane...	Best Practice Nicotine Replac... Quality-of-Life... Questionnaire A...	21 Years -	Ohio State University Comprehensive Cancer Center
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung	NCT05412875	Head and Neck S... Lung Non-Small ... Stage I Cutaneo... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage II Cutane... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Cutan... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Cutane...	Best Practice Nicotine Replac... Quality-of-Life... Questionnaire A...	21 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage i cutaneous squamous cell carcinoma of the head and neck ajcc v8