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

Ohio State University Comprehensive Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Feasibility of patients measured by number of screened per month

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

Time frame: Up to 6 months

Feasibility of patients measured by number of screened per month by eligibility status

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

Time frame: Up to 6 months

Feasibility of patients measured by number of screened per month by refusal status

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

Time frame: Up to 6 months

Reasons for participant ineligibility

We will record reasons for patient ineligibility

Time frame: Baseline

Reasons for participant refusal

We will record reasons for patient refusal to participate

Time frame: Baseline

Acceptance measured by participation rate

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

Time frame: Up to 6 months

Compliance

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

Time frame: Up to 6 months

Adherence

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

Time frame: Baseline and hospital admission for surgery

Incidence of adverse events (AEs)

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.

Time frame: Up to 14 days after delivery of intervention

Complication rate (primary preliminary efficacy)

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

Time frame: Up to 6 months

Quality of life (QOL) - anxiety & depression

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

Time frame: Up to 6 months

Quality of life (QOL) - anxiety & depression 2

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

Time frame: Up to 6 months

Quality of life (QOL) - Perceptions of cancer

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)

Time frame: Up to 6 months

Quality of life (QOL) - Health outcomes

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

Time frame: Up to 6 months

Quality of life (QOL) - Health outcomes 2

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).

Time frame: Up to 6 months

7 day point prevalence of tobacco use

7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups

Time frame: Up to 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes