Smoking Cessation Intervention for Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Nicotine patch

Disqualifiers: Distant metastatic cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover better methods to help cancer patients quit smoking before and after surgery. It compares two approaches: one where participants gradually reduce smoking before using a nicotine patch, and another that combines counseling with a nicotine patch (nicotine replacement therapy). The researchers hope to enhance current programs that assist people in quitting tobacco. This trial suits individuals who smoke more than 8 cigarettes a day, have been diagnosed with cancer or have a suspicious mass, and are planning surgery soon. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches in smoking cessation for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation methods for cancer patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both treatment options in this study—Hospital Counseling with Nicotine Replacement Therapy (HC+NRT) and adding Pre-surgical Scheduled Reduced Smoking (HC+NRT+PS/SRS)—are generally safe for people.

For the HC+NRT approach, studies indicate that using nicotine patches along with counseling helps many cancer patients quit smoking. Reports suggest that this combination is well-tolerated, with nearly half of the participants quitting smoking for up to nine months.

The HC+NRT+PS/SRS method involves gradually reducing smoking before surgery, then using nicotine patches. Although this specific approach hasn't significantly improved quitting rates compared to the standard method, it doesn't seem to cause any additional side effects.

Overall, these treatments are considered safe, especially since nicotine replacement therapy is widely used and approved for helping people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the smoking cessation treatments being studied because they offer a unique approach to helping cancer patients quit smoking. Traditional options like nicotine replacement therapy (NRT) typically focus on replacing nicotine in a gradual process. However, one of these new treatments combines hospital counseling and NRT with a presurgical scheduled reduced smoking (PS/SRS) plan, which aims to strategically reduce smoking before surgery. This method could potentially enhance readiness for surgery, improve recovery outcomes, and offer a more structured path to quitting smoking. By integrating this scheduled reduction approach, researchers hope to address both the physical addiction and the behavioral aspects of smoking, offering a more comprehensive cessation strategy.

What evidence suggests that this trial's treatments could be effective for smoking cessation in cancer patients?

Research has shown that combining hospital counseling with nicotine replacement therapy (HC+NRT), one of the treatment options in this trial, helps many cancer patients quit smoking. In one study, almost half of the patients stopped smoking after joining a comprehensive program. Follow-up surveys found that 45% to 46% of participants remained smoke-free for several months. Another treatment arm in this trial includes adding a presurgical scheduled reduced smoking program (HC+NRT+PS/SRS). However, studies have indicated that this addition did not improve quitting rates compared to standard methods. Overall, ongoing counseling and medication effectively help cancer patients quit smoking. ^{1 2 3 5 6}

Who Is on the Research Team?

Jamie Ostroff, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cancer or a mass that might be cancer, who are not in the distant metastatic stage and are candidates for surgery in no less than 7 days. Participants must be mentally sound, able to use a phone and PDA, willing to consent, and smoke more than 8 cigarettes daily or frequently use other tobacco.

Inclusion Criteria

Have manual dexterity and sensory (i.e., visual and auditory) acuity sufficient to use a Personal Digital Assistant (PDA)

Provide informed consent.

I smoke more than 8 cigarettes a day and have smoked in the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Smoking Cessation

Participants engage in a scheduled reduced smoking program followed by use of the nicotine patch

4-6 weeks

Weekly visits (in-person)

Treatment

Participants receive hospital counseling and nicotine replacement therapy

Duration not specified

Follow-up

Participants are monitored for smoking cessation success and any health improvements post-surgery

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking
• Hospital Counseling + Nicotine Replacement Therapy

Trial Overview The study compares two smoking cessation methods before surgery: one uses scheduled reduced smoking plus nicotine patches; the other employs hospital counseling alongside nicotine patches. The goal is to determine which method better helps patients quit tobacco use pre- and post-surgery.

How Is the Trial Designed?

Group I: 2 Experimental Treatment 1 Intervention

Hospital Counseling + Nicotine Replacement Therapy + Pre-surgical Schedule Reduced Smoking (HC+NRT+PS/SRS)

Group II: 1 Active Control 1 Intervention

Hospital Counseling + Nicotine Replacement Therapy (HC+NRT)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A randomized controlled trial involving 137 cancer patients found that a motivational interviewing intervention did not significantly increase smoking cessation rates compared to usual care, with both groups showing low quit rates at 6 months (5% for intervention vs. 6% for control).

However, a sensitivity analysis suggested that the intervention group had a higher quit rate (29%) compared to the control group (18%), indicating that while the intervention may not have been statistically significant, it could still have potential benefits that warrant further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Wakefield, M., Olver, I., Whitford, H., et al.[2022]

A study involving 246 clinicians and 2,146 cancer patients showed that electronic health record (EHR) nudges aimed at clinicians significantly increased tobacco use treatment (TUT) referrals and prescriptions, with TUT penetration rising from 13.5% in usual care to 35.6% with clinician nudges.

The results indicate that while clinician nudges were effective, adding patient nudges did not further enhance TUT engagement, suggesting that targeting clinicians may be the most effective strategy for improving tobacco treatment in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke. Jenssen, BP., Schnoll, R., Beidas, RS., et al.[2023]

In a study involving 274 hospitalized smokers, those who received nicotine replacement therapy (NRT) combined with counseling had significantly higher smoking abstinence rates at discharge (55%) and at 12 months (17%) compared to those receiving counseling alone (43% and 6%) or usual care (37% and 8%).

The results suggest that providing NRT alongside brief counseling is an effective smoking cessation strategy for hospitalized patients, while counseling alone did not show significant benefits over usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Molyneux, A., Lewis, S., Leivers, U., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23895203/

Randomized trial of a presurgical scheduled reduced ... Conclusion: Compared to best practices for treating tobacco dependence, a presurgical, scheduled reduced smoking intervention did not improve abstinence rates ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00575718

Smoking Cessation Intervention for Cancer Patients ... The purpose of this study is to see if we can find ways to improve the treatment of tobacco dependence in patients who have cancer or may have cancer. We will ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4116187/

Randomized Trial of a Pre-Surgical Scheduled Reduced ... Compared to best practices for treating tobacco dependence, a pre-surgical, scheduled reduced smoking intervention did not improve abstinence rates among newly ...

4. psycnet.apa.org psycnet.apa.org/record/2013-26998-001

Randomized trial of a presurgical scheduled reduced smoking ... Objective: Cancer patients who smoke are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was ...

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

The effectiveness of smoking cessation interventions after ... A combination of pharmacological and behavioural interventions may be the most effective intervention for smoking cessation in patients with cancer.

6. withpower.com withpower.com/trial/phase-9-2002-1725d

Smoking Cessation Intervention for Cancer Patients The results suggest that providing NRT alongside brief counseling is an effective smoking cessation strategy for hospitalized patients, while counseling alone ...