Nicotine Replacement for Relapse

Phase-Based Estimates
Aurora BayCare Medical Center, Green Bay, WI
Relapse+7 More
Nicotine Replacement - Drug
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether virtual counseling sessions may help tobacco-dependent cancer patients quit smoking.

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Eligible Conditions

  • Relapse
  • Recurrence
  • Cancer
  • Carcinoma in Situ
  • Neoplasms
  • Recurrent Neoplasm
  • Neoplasms, Malignant
  • Primary Neoplasm
  • Carcinoma In Situ
  • Current Smokers

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Nicotine Replacement will improve 1 primary outcome, 4 secondary outcomes, and 11 other outcomes in patients with Relapse. Measurement will happen over the course of Up to 6 months.

At 3 months
Biochemically-confirmed 7-day point prevalence abstinence by saliva cotinine or expired air CO
At 6 months
7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)
Self-reported 7-day point prevalence abstinence
Self-reported continuous tobacco abstinence
Sustained tobacco abstinence at 6 months
Up to 24 months
Implementation of the intervention at community oncology sites
Intervention acceptability (satisfaction with content/delivery) at community oncology sites
Intervention adoption (program uptake) at community oncology sites
Intervention appropriateness (relevance) at community oncology sites
Intervention cost at community oncology sites
Intervention penetration (reach) at community oncology sites
Intervention sustainability at community oncology sites
Treatment fidelity/adaptation at community oncology sites
Up to 6 months
Potential effect of cancer variables on treatment effectiveness
Potential effect of medical and smoking history on treatment effectiveness
Potential effect of sociodemographics on treatment effectiveness

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm A (smoking assessment, quitting advice, Quitline referral)
Arm B (virtual counseling sessions, NRT)

This trial requires 418 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nicotine Replacement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm B (virtual counseling sessions, NRT)Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).
Arm A (smoking assessment, quitting advice, Quitline referral)Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 months for reporting.

Closest Location

Aurora BayCare Medical Center - Green Bay, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who have been diagnosed with any type of cancer in the past 4 months are eligible for the study show original
The patient must have smoked a cigarette in the past 30 days in order to be eligible for the study. show original
The study only involves people who have access to the internet or email because the study is assessing how well the virtual intervention works in the NCORP network. show original
A patient must have completed a baseline survey in the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within one month of the date of informed consent in order to be eligible for the study. show original
The text says that the person must speak English. show original
You must have worked at a NCORP site for at least three months. show original
The patient must be fluent in both English and Spanish, either written or spoken. show original
Patient must have access to a telephone, the internet, and email. show original
The patient must still meet all the eligibility criteria outlined in step 0. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does nicotine replacement improve quality of life for those with relapse?

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This pilot study suggests that nicotine replacement therapy has a short term, modest, but statistically significant improvement on three measures of HRQoL, when used in smoking cessation.

Unverified Answer

How many people get relapse a year in the United States?

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Every year during the last 5 years, around 47 million Americans can expect to have a relapse episode, and about 21 million will develop one. When relapse is examined by gender, it is most common in women and tends to occur more often after a period of remission, a condition known as relapsing-remitting type of arthritis.

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What is relapse?

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A relapse is a return of a disease or symptoms that is related to the original illness. Relapse can occur in patients with many cancers (including breast cancer, lung cancer), including patients with cancer which is stable after treatment. The risk of a relapse after treatment is also a significant problem for women with breast cancer. Relapse may recur from months to many years after remission, and it may develop in response to new exposure to disease-causing environmental triggers including treatment. Relapse in a cancer patient typically does not occur because the disease dies off or changes into a different types of cells, but from new growth within a tumour or spread to another part of the body. Relapse rates with different types of cancer are about the same.

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What causes relapse?

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There were multiple factors that predicted a relapse in a study of over 80,000 patients treated in a community mental health service which included all the variables considered to affect outcome. The findings were particularly important because little is known about this group. Other studies are needed before they can influence treatment in a community mental health service.

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What are common treatments for relapse?

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Relapse to a new depressive episode can be prevented when treatments are adjusted and adjusted as needed to the needs and circumstances of each patient or group. If an antidepressant in good or very good maintenance tolerability is indicated, relapse is unlikely without ongoing treatment. Those who have not responded adequately to a regimen can be switched to a more active one. Treatment of relapse is often intensive including a combination of psychotherapy, mood stabilizer drugs, and, if necessary, electroconvulsive therapy or other psychiatric medications. Follow up and monitoring are essential for all patients treated in this way.

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What are the signs of relapse?

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Relapse has been used as an indicator of treatment response because it represents the final stage of recovery. Most relapse is in the form of symptoms which may present months or years after initial recovery. Signs of relapse can be pain, swelling and redness, or muscle tenderness and limitation of activity.

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Can relapse be cured?

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The majority of the patients are able to be cured after relapses. Early identification, close follow-up and early treatment (a first course of chemotherapy) are necessary to prevent relapses and to maximize the prospects of cure.

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Is nicotine replacement typically used in combination with any other treatments?

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Among this sample of smokers with a current or past history of addiction who were medically eligible for pharmacotherapies, there was a low rate of NRT use in combination with other pharmacotherapies. Among those smoking with a history of addiction, NRT was more commonly used in combination with BSSS, SSRIs, and bupropion.

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What is the primary cause of relapse?

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There is no common cause of relapse in CLL. The current treatments reduce and monitor the clones responsible for relapse and so are very important for determining the risk of relapse.

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Have there been other clinical trials involving nicotine replacement?

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In light of the recent results reported by Zablotsky (2010), with regard to the role of nicotine in reducing cancer risk, further large randomized controlled trials investigating potential synergistic effect of smoking cessation with the use of NRTIs are warranted.

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Who should consider clinical trials for relapse?

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Among patients that have undergone clinical trials to treat a relapse, patients that responded to their first treatment had the highest relapse rate at 2.13%. This suggests that a relapse of the disease should take into consideration the type of treatment that was administered to the patient.

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What is nicotine replacement?

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Findings suggest there is no reason to reject the idea that nicotine replacement helps smokers manage symptoms. It is acceptable for smokers with a diagnosis of MS to be actively seeking nicotine replacement.

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