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

204 Participants Needed

Trial Summary

What is the purpose of this trial?

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 compare two ways to help people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled reduced smoking program followed by use of the nicotine patch. In this program, the tobacco user will gradually cut down on their tobacco use until they quit. Once they quit, they will be offered the nicotine patch. We will compare this approach to our current program of counseling and use of nicotine patch. What we learn from this study may help us to develop new ways to help tobacco users and improve our current smoking cessation program.

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.

What data supports the effectiveness of this treatment for smoking cessation in cancer patients?

Research shows that quitting smoking after a cancer diagnosis can improve treatment success and survival rates. Hospital-based tobacco treatments and motivational interviewing have been effective in helping cancer patients stop smoking, which can lead to better health outcomes. ^{1 2 3 4 5}

Is the smoking cessation treatment safe for cancer patients?

The treatment, which includes hospital counseling and nicotine replacement therapy, has been used safely in hospital settings for patients, including those with a history of cancer, to help them quit smoking. ^{2 4 6 7 8}

How is the Smoking Cessation Intervention for Cancer Patients treatment different from other treatments?

This treatment is unique because it combines hospital counseling, nicotine replacement, and a presurgical plan to gradually reduce smoking, specifically tailored for cancer patients. This comprehensive approach is designed to improve treatment outcomes and survival by addressing smoking habits before surgery, which is not commonly done in standard smoking cessation programs. ^{1 4 9 10 11}

Research Team

Jamie Ostroff, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

I am 18 years old or older.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Brief preoperative smoking cessation counselling in relation to breast cancer surgery: a qualitative study. [2009]

3. United States 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hospital-based tobacco treatment for inpatients with a history of cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Tobacco use in women with lung cancer. [2019]

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

Preoperative intervention for smoking cessation: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Utilizing audit and feedback to improve hospitalists' performance in tobacco dependence counseling. [2010]

8. England 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. [2019]

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

Smoking cessation potential among newly diagnosed cancer patients: a population-based study of the ten most common cancers in Massachusetts, USA, 2008-2013. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Predictors of smoking cessation among cancer patients enrolled in a smoking cessation program. [2022]

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

Catalyst for Change: Measuring the Effectiveness of Training of All Health Care Professionals to Provide Brief Intervention for Smoking Cessation to Cancer Patients. [2021]