Clinical trial NCT05805722: Comprehensive Tobacco Cessation for Cancer Patients and Survivors
Official title: Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: "A Breath of Fresh Air"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.

Detailed description: The goal of this study is to generate knowledge regarding the feasibility and acceptability of integrating tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers. The evidence base regarding tobacco treatment is solid: pharmacology (nicotine replacement therapy (and/or), bupropion, or varenicline) in combination with behavioral counseling yields the best results with respect to cessation rates. What remains unclear is how best to offer and implement this comprehensive treatment in the context of a cancer center-especially in a patient population facing social determinants of health that may not be in favor of tobacco cessation. Thus, in this study, the investigators are offering the "gold standard" tobacco treatment and assessing feasibility and acceptability of these procedures in order to inform future efforts to optimize treatment delivery for this unique population and setting. The intervention for this protocol was approved for standard of care use.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with study procedures and availability for the duration of the study
* Have a documented history of cancer of any type, whether active or in remission
* Identify as a current or recently-quit tobacco user

Exclusion Criteria:

* Not a VCUHealth patient
* Non English-speaking

Primary outcomes:
measure: Feasibility: Consent rate
timeFrame: At enrollment visit
measure: Feasibility: Barriers to participation
timeFrame: At recruitment visit
measure: Acceptability: Participant satisfaction
timeFrame: Week 6
measure: Acceptability: Participant satisfaction
timeFrame: Week 12
measure: Acceptability: Participant satisfaction
timeFrame: Week 24
measure: Acceptability: Behavioral counseling attendance
timeFrame: 12 weeks
measure: Acceptability: Nicotine replacement therapy adherence
timeFrame: Week 6
measure: Acceptability: Nicotine replacement therapy adherence
timeFrame: Week 12
measure: Acceptability: Nicotine replacement therapy adherence
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
measure: Change in tobacco use
timeFrame: Baseline to Week 12
measure: Change in tobacco use
timeFrame: Baseline to Week 24
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Livingstone Aduse-Poku, PhD
role: PRINCIPAL_INVESTIGATOR
References: