Comprehensive Tobacco Cessation for Cancer Patients and Survivors

NCT ID: NCT05805722

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Tobacco Use Cessation Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral counseling for tobacco cessation

Intervention Type 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

Observational Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Livingstone Aduse-Poku, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Antonice Wall

Role: CONTACT

804-827-2357

Massey CPCTeam

Role: CONTACT

804-828-1965

Facility Contacts

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Antonice Wall

Role: primary

804-628-6430

Massey CPC Team

Role: backup

804-828-1965

Other Identifiers

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HM20026004

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-22-19970

Identifier Type: -

Identifier Source: org_study_id

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