Recruiting

Tobacco Cessation

Sponsor:

Virginia Commonwealth University

Code:

NCT05805722

Conditions

Tobacco Use Cessation

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral counseling for tobacco cessation

Study Details

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.

Conditions

Tobacco Use Cessation

Cancer

Study ID

NCT05805722

Start date

Apr 12, 2023

Status verified date

Jun, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Behavioral Counseling for Tobacco Cessation

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.

no intervention: Observational Arm

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

Interventions

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

Primary outcome measure

  • Feasibility: Consent rate [ Time Frame: At enrollment visit ]
  • Feasibility: Barriers to participation [ Time Frame: At recruitment visit ]
  • Acceptability: Participant satisfaction [ Time Frame: Week 6 ]
  • Acceptability: Participant satisfaction [ Time Frame: Week 12 ]
  • Acceptability: Participant satisfaction [ Time Frame: Week 24 ]
  • Acceptability: Behavioral counseling attendance [ Time Frame: 12 weeks ]
  • Acceptability: Nicotine replacement therapy adherence [ Time Frame: Week 6 ]
  • Acceptability: Nicotine replacement therapy adherence [ Time Frame: Week 12 ]
  • Acceptability: Nicotine replacement therapy adherence [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Livingstone Aduse-Poku, Ph.D

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-06-30.