Intensive Tobacco Treatment for Smoking Cessation in Cancer Patients

Overseen By Kayla Fay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Unable to consent, prisoners

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an intensive program helps cancer patients quit smoking more effectively. It compares a comprehensive support program, which includes frequent counseling and possibly medication, to standard smoking cessation options. The researchers aim to determine which method helps more people quit smoking at various checkpoints: 30 days, 3 months, and 6 months. This trial may suit those actively smoking and undergoing cancer treatment who wish to quit. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could improve smoking cessation strategies for cancer patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intensive tobacco treatment is safe for cancer patients?

Research has shown that intensive programs to help cancer patients quit smoking are generally safe. Nearly half of the participants in these programs have successfully quit smoking within a few months, indicating that the treatment is well-tolerated.

Although specific details about side effects aren't provided, the focus on counseling and support suggests that any negative effects are likely minor. This is because the treatment primarily involves behavioral support and possibly medication, which are usually safe when used correctly.

Overall, evidence suggests that intensive tobacco treatment is a safe choice for cancer patients who want to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Intensive Tobacco Treatment because it offers a more personalized and frequent support system for cancer patients trying to quit smoking. Unlike standard care, which typically involves less frequent contact and primarily relies on referrals to services like Quitline, this approach includes regular biweekly check-ins with a certified tobacco treatment specialist. This method provides intensive counseling and can be tailored with pharmacotherapy as needed, potentially increasing the likelihood of successful smoking cessation through close, consistent support.

What evidence suggests that the Intensive Tobacco Treatment could be effective for smoking cessation in cancer patients?

This trial will compare an Intensive Tobacco Treatment program with Usual Tobacco Treatment for smoking cessation in cancer patients. Studies have shown that a focused program to help people quit smoking can be very effective for cancer patients. Almost half of the participants in these programs successfully stop smoking, increasing their chances of living longer by 30% to 40%. Quitting smoking soon after a cancer diagnosis can add about two years to a person's life. Research also indicates that stopping smoking around the time of diagnosis lowers the risk of cancer returning. These programs typically include counseling and medication, which together can significantly improve the chances of quitting smoking for good. ^{2 3 6 7 8}

Who Is on the Research Team?

Joseph D Phillips, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are actively smoking at the time of their initial cancer consultation, which means they've smoked within the last two weeks. It's not open to those unable to consent or prisoners.

Inclusion Criteria

You have been smoking within the past two weeks before your consultation for cancer.

Exclusion Criteria

Prisoners

I am unable to give consent for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Tobacco Treatment

Participants receive intensive tobacco treatment with carbon monoxide monitoring, including counseling and pharmacotherapy as needed

6 months

Initial in-person visit, then biweekly via telephone or telehealth

Follow-up

Participants are monitored for cessation success rates at 30 days, 3 months, and 6 months

6 months

3 additional survey time points

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Tobacco Treatment

Trial Overview The CORE study is testing how well an intensive tobacco treatment program helps cancer patients quit smoking. Success rates will be checked after 30 days, and then again at 3 and 6 months into the treatment.

How Is the Trial Designed?

Group I: Intensive Tobacco Treatment Experimental Treatment 1 Intervention

Patients who consent to study participation will meet with a tobacco treatment specialist in-person initially, then biweekly via telephone or telehealth or face-to-face (or more frequently as needed). They will receive tobacco treatment counseling and support from certified tobacco treatment specialist, which may include pharmacotherapy as indicated. At enrollment, participants will undergo carbon monoxide testing using a carbon monoxide monitor. At baseline, participants will complete the Fagerström Test for Nicotine Dependence, and the Cancer Patient Tobacco Use Questionnaire (C-TUQ). These tobacco related survey measures will be completed at 3 additional time points: 30 days, 3 months and 6 months.

Group II: Usual Tobacco Treatment Active Control 1 Intervention

All individuals who are identified as tobacco users are offered tobacco treatment which includes proactive, as needed, contacts via in person, telehealth or telephone visits. for tobacco treatment, pharmacotherapy as indicated, and Quitline and SmokefreeTXT referrals

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8295883/

Effective Cessation Treatment for Patients with Cancer Who ... It shows that an intense smoking treatment program involving extended counseling and pharmacotherapy can produce impressively high rates of ...

2. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2024/10/31/report-quantifies-survival-benefit-quitting-smoking-after-cancer-diagnosis

Hollings smoking cessation expert determines benefits of ... Quitting smoking soon after a cancer diagnosis adds an average of two years to a patient's life, a new study finds.

3. mdanderson.org mdanderson.org/newsroom/study-shows-nearly-half-of-cancer-patients-who-enter-a-comprehensive-tobacco-treatment-program-quit-smoking.h00-159306201.html

Study shows nearly half of cancer patients who enter a ... “The truth is, quitting at time of diagnosis increases the chance of survival by 30% to 40%. Patients also have less chance of a recurrence or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213538323000802

The effectiveness of smoking cessation interventions after ... [10] Newly diagnosed cancer patients who quit around diagnosis have higher overall survival, higher disease free survival and similar treatment side effect ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9173433/

Increased Reach and Effectiveness with a Low-Burden ... Effectiveness: The proportion of tobacco smokers who subsequently achieved cessation increased significantly from pre-ELEVATE to post-ELEVATE (12.0% vs. 17.2%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4377321/

Tobacco Use and Cessation for Cancer Survivors Smoking accounts for at least 30% of all cancer deaths and nearly 90% of lung cancer deaths. Almost 62% of all recently diagnosed cancer patients are reportedly ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2771608

Effect of Sustained Smoking Cessation Counseling and ... Follow-up survey completion rates at 6 months were 81.8% (n = 121/148) in the intensive treatment group and 74.1% (n = 100/135) in the standard ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04198688

Effectiveness of Intensive Smoking Cessation Interventions ... Self-reported patient-satisfaction, questionnaire completed by telephone interview, 6 months. % of patients that are compliant to the treatment, Counsellor ...