Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use
NCT04694846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-09-09
Summary
This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.
Conditions
- Lung Non-Small Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
Interventions
- DRUG
-
Nicotine Replacement
Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
- DRUG
-
Bupropion Hydrochloride Controlled-release
Given PO
- DRUG
-
Varenicline
Given PO
- OTHER
-
Tobacco Cessation Counseling
Receive counseling
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Quality of Life Assessment
Ancillary studies
- OTHER
-
Best Practice
Receive standard treatment
Sponsors & Collaborators
-
Thomas Jefferson University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-19
- Primary Completion
- 2024-08-16
- Completion
- 2024-08-16
Countries
- United States
Study Locations
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