Comprehensive Tobacco Cessation for Cancer Patients and Survivors

NCT05805722 | Recruiting DMC

• 2 other identifiers: MCC-22-19970HM20026004
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Feasibility: Consent rate

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

  At enrollment visit

• Feasibility: Barriers to participation

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

  At recruitment visit

• 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

• 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

• 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

• Acceptability: Behavioral counseling attendance

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

  12 weeks

• 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

• 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

• 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

Other Outcomes (2)

• Change in tobacco use

  Baseline to Week 12

• Change in tobacco use

  Baseline to Week 24

Study Arms (2)

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.

Behavioral: Behavioral counseling for tobacco cessation

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

Interventions

Behavioral counseling for tobacco cessation BEHAVIORAL

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

Behavioral Counseling for Tobacco Cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not a VCUHealth patient
• Non English-speaking

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation; Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Livingstone Aduse-Poku, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonice Wall

CONTACT

804-827-2357; walla2@vcu.edu

Massey CPCTeam

CONTACT

804-828-1965; MasseyCPC@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 10, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)