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Clinical Trials/NCT05805722
NCT05805722RecruitingNot Applicable

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

Virginia Commonwealth University2 sites in 1 country75 target enrollmentStarted: April 12, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
75
Locations
2
Primary Endpoint
Acceptability: Participant satisfaction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Behavioral Counseling for Tobacco Cessation

Experimental

Behavioral counseling for tobacco cessation consists of psychoeducation in combination with evidence-based behavior change techniques including stimulus control, self-monitoring, goal-setting, implementation planning, and problem-solving. Specific content topics include the harms of smoking/benefits of quitting, coping with cravings and withdrawal, setting a quit date, managing social influences, and relapse prevention.

Intervention: Behavioral counseling for tobacco cessation (Behavioral)

Observational Arm

No Intervention

Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities

Outcomes

Primary Outcomes

Acceptability: Participant satisfaction

Time Frame: Week 24

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.

Feasibility: Barriers to participation

Time Frame: At recruitment visit

Reasons for refusal will be collected for eligible individuals who do not enroll in the study.

Acceptability: Nicotine replacement therapy adherence

Time Frame: Week 24

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).

Feasibility: Consent rate

Time Frame: At enrollment visit

The number of individuals who consented to participate compared to the number of individuals approached for study participation.

Acceptability: Behavioral counseling attendance

Time Frame: 12 weeks

Participant attendance at scheduled group or 1:1 behavioral intervention sessions

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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