Comprehensive Tobacco Cessation for Cancer Patients and Survivors

Cancer Clinical Trial

Official title:

Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: "A Breath of Fresh Air"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05805722
• Other study ID #: MCC-22-19970
• Secondary ID: HM20026004
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Tobacco Use Cessation

Intervention

Behavioral:
• Behavioral counseling for tobacco cessation
Participants can choose to receive behavioral counseling in group v. individual format: Group Sessions: Participants will be offered the opportunity to attend 6 weekly 60-90 minute sessions Individual Sessions: Participants will be offered the opportunity to attend up to 12 30-45 minute sessions on a schedule mutually agreed upon between interventionist and participant

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in tobacco use	Self-reported change in number of cigarettes smoked	Baseline to Week 12
Other	Change in tobacco use	Self-reported change in number of cigarettes smoked	Baseline to Week 24
Primary	Feasibility: Consent rate	The number of individuals who consented to participate compared to the number of individuals approached for study participation.	At enrollment visit
Primary	Feasibility: Barriers to participation	Reasons for refusal will be collected for eligible individuals who do not enroll in the study.	At recruitment visit
Primary	Acceptability: Participant satisfaction	Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.	Week 6
Primary	Acceptability: Participant satisfaction	Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.	Week 12
Primary	Acceptability: Participant satisfaction	Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.	Week 24
Primary	Acceptability: Behavioral counseling attendance	Participant attendance at scheduled group or 1:1 behavioral intervention sessions	12 weeks
Primary	Acceptability: Nicotine replacement therapy adherence	Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written).	Week 6
Primary	Acceptability: Nicotine replacement therapy adherence	Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written).	Week 12
Primary	Acceptability: Nicotine replacement therapy adherence	Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written).	Week 24