Behavioral Counseling for Quitting Smoking in Cancer Patients

Overseen By CTO Operations Managers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Non VCUHealth patient, Non English-speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Behavioral counseling for tobacco cessation in cancer patients?

Research shows that behavioral counseling can significantly help people quit smoking, which is crucial for cancer patients as smoking can worsen their treatment outcomes. Effective behavioral treatments, when combined with other methods, have been shown to improve quitting success and overall health in cancer care. ^{1 2 3 4 5}

Is behavioral counseling for quitting smoking safe for cancer patients?

Behavioral counseling for quitting smoking is generally considered safe for humans, including cancer patients, as it involves non-invasive methods like motivational interviewing and support through phone calls or written materials. ^{2 3 6 7 8}

How is behavioral counseling for quitting smoking in cancer patients different from other treatments?

Behavioral counseling for quitting smoking in cancer patients is unique because it focuses on personalized support and strategies to help patients quit smoking, rather than relying on medications. This approach can be more cost-effective and is tailored to the specific needs and motivations of cancer patients, who may face unique challenges in quitting smoking. ^{1 2 9 10 11}

Research Team

Susan Hong, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for current or recently-quit tobacco users who have had cancer of any type, are willing to follow the study rules, and can stay in the study until it ends. They must understand English and be patients at VCUHealth.

Inclusion Criteria

I have a history of cancer, whether it's active or in remission.

Provision of signed and dated informed consent form

Stated willingness to comply with study procedures and availability for the duration of the study

Exclusion Criteria

Not a VCUHealth patient

Non English-speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral counseling and pharmacotherapy for tobacco cessation

12 weeks

Regular visits for behavioral intervention sessions

Follow-up

Participants are monitored for changes in tobacco use and satisfaction with the intervention

12 weeks

Follow-up assessments at Week 24

Treatment Details

Interventions

• Behavioral counseling for tobacco cessation

Trial Overview The study is testing how well behavioral counseling helps cancer patients, survivors, and caregivers stop using tobacco when it's part of their regular clinical care.

Participant Groups

Group I: Behavioral Counseling for Tobacco Cessation Experimental Treatment 1 Intervention

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 II: Observational Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

Behavioral treatments for tobacco use are effective and cost-effective, comparable to pharmacotherapies, but have not advanced as quickly in recent years.

There is a need for more research on tobacco cessation interventions specifically for cancer patients, and clinicians are encouraged to use the Five A's approach to support these patients in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? Brandon, TH.[2007]

Tobacco use is a significant risk factor for cancer and negatively impacts cancer prognosis, yet effective cessation treatments are underutilized in oncology settings.

Implementing a comprehensive tobacco treatment program, which includes automatic referrals, motivational interviewing, and combined behavioral and pharmacological interventions, can significantly enhance smoking cessation success and improve health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. Kaiser, EG., Prochaska, JJ., Kendra, MS.[2023]

Continued tobacco use after a cancer diagnosis significantly worsens treatment outcomes, increasing toxicity, recurrence, second tumors, and mortality rates among cancer patients.

Quitting smoking after a cancer diagnosis is associated with improved treatment outcomes, and patients are generally receptive to evidence-based cessation support, highlighting the need for better access and efficacy of cessation programs in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco use in the oncology setting: advancing clinical practice and research. Gritz, ER., Toll, BA., Warren, GW.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral and pharmacologic approaches to smoking cessation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? [2007]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. [2023]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Treatment of tobacco dependence as a standard part of oncology care. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Effects of stage-matched repeated individual counseling on smoking cessation: A randomized controlled trial for the high-risk strategy by lifestyle modification (HISLIM) study. [2021]

6. China pubmed.ncbi.nlm.nih.gov

Tobacco smoking after diagnosis of cancer: clinical aspects. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Tobacco use and cessation for cancer survivors: an overview for clinicians. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Tobacco use in the oncology setting: advancing clinical practice and research. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Smoking and smoking cessation in cancer patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Smoking Cessation, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Smoking cessation counseling by Russian oncologists: opportunities for intervention in the Russian Federation. [2018]