Smoking Cessation Treatment for Head & Neck Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Varenicline

Must not be taking: Bupropion, Nortriptyline, Clonidine, Nicotine

Disqualifiers: Severe depression, Pregnancy, Others

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of counseling more effectively helps people quit smoking: Acceptance and Commitment Therapy (ACT) or Motivational and Behavioral Counseling (MBC). Researchers are testing both counseling types on patients with certain types of cancer, including head and neck, lung, breast, gastrointestinal, or genitourinary cancer. Participants will also take varenicline, a medication used to help people quit smoking. This trial may be suitable for individuals who have cancer, smoke at least one cigarette a day, and are receiving treatment or follow-up care at M.D. Anderson Cancer Center.

As an Early Phase 1 trial, this research focuses on understanding how these counseling methods work in people, offering participants a chance to contribute to groundbreaking insights in smoking cessation for cancer patients.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications like bupropion, nortriptyline, clonidine, or nicotine replacement therapy. If you are currently using these, you would need to stop before participating.

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

Research has shown that Acceptance and Commitment Therapy (ACT) can help people quit smoking by improving mental flexibility, making it easier to manage the discomfort of quitting. Past studies have well-received this therapy, reporting no major side effects.

Motivational and Behavioral Counseling (MBC) is another effective method for quitting smoking. It increases motivation and helps people develop quitting strategies. While specific safety details are not provided, this method is well-known and generally considered safe for quitting smoking.

Both groups in the trial will also use varenicline, a medication that aids in smoking cessation. Studies indicate that varenicline is effective and generally safe, though it can cause side effects like nausea or sleep problems. Monitoring for any side effects and discussing them with healthcare providers is important.

Participants should consider these findings and consult their doctors when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking cessation in head and neck cancer patients because they combine psychological support with medication. Acceptance and Commitment Therapy (ACT) and Motivational and Behavioral Counseling (MBC) are paired with varenicline, a medication that reduces cravings and withdrawal symptoms. Unlike standard treatments that often focus solely on nicotine replacement, these approaches integrate mental health strategies to address the psychological aspects of smoking addiction. This dual approach could offer a more comprehensive solution, potentially improving quit rates and supporting long-term success in quitting smoking.

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

Research has shown that Acceptance and Commitment Therapy (ACT) can help people quit smoking. Some studies provided ACT over the phone or online, yielding positive results. This therapy aids individuals in accepting their thoughts and feelings while committing to positive changes. In this trial, one group of participants will receive ACT along with Varenicline.

Motivational and Behavioral Counseling (MBC) is another method that encourages smoking cessation by boosting motivation and helping individuals develop plans to quit. Studies indicate that quitting smoking, especially when diagnosed with cancer, can lower the risk of death by 30-40% and improve treatment outcomes. Another group in this trial will receive MBC along with Varenicline.

This trial tests both therapies to determine which is more effective in helping people with cancer quit smoking. ^{1 3 4 6 7}

Who Is on the Research Team?

Jan Blalock, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with a current or past diagnosis of head and neck, lung, breast, gastrointestinal, or genitourinary cancer who smoke. They must be recommended for varenicline treatment and able to consent to study procedures. Exclusions include planned long hospital stays, certain surgeries, use of specific smoking cessation drugs or treatments, severe depression or psychiatric risk factors.

Inclusion Criteria

Willing to provide informed consent and agree to all assessments and study procedures

I am receiving or plan to receive cancer treatment at M.D. Anderson for specific cancers.

I have or had cancer in my head, neck, lung, breast, stomach area, or reproductive organs.

Exclusion Criteria

I am currently using bupropion, nortriptyline, clonidine, or nicotine replacement therapy.

I have received treatment in the time to progression.

I am scheduled for a complete removal of my voice box.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Tests

Participants complete baseline questionnaires and saliva tests

1 week

1 visit (in-person)

Treatment

Participants receive either Acceptance and Commitment Therapy or Motivational and Behavioral Counseling, along with varenicline

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for smoking abstinence and complete questionnaires

3 months

1 visit (in-person)

Extended Follow-up

Participants have an additional follow-up to assess long-term smoking abstinence

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy
• Motivational and Behavioral Counseling
• Varenicline

Trial Overview The study compares two types of counseling: Acceptance and Commitment Therapy (investigational) versus Motivational and Behavioral Counseling (standard). It aims to determine which is more effective in helping patients quit smoking alongside their prescribed varenicline treatment.

How Is the Trial Designed?

Group I: MBC Group 2 Experimental Treatment 2 Interventions

Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.

Group II: ACT Group 1 Experimental Treatment 2 Interventions

Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 203 post-treatment cancer survivors identified three symptom severity classes, revealing that those with higher symptom burdens (like fatigue and anxiety) showed lower levels of mindfulness and acceptance.

The results support the Acceptance and Commitment Therapy (ACT) model, suggesting that survivors with greater symptom distress are less engaged in meaningful activities and less accepting of their experiences, highlighting the need for further research on ACT's effectiveness in alleviating suffering in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. Lewson, AB., Johns, SA., Krueger, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01098955

Smoking Cessation Treatment for Head & Neck Cancer ... The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11535697/

Effectiveness of acceptance commitment therapy for head ... ACT has been shown to have significant results for BID due to weight, size, height, skin colour and other aspects of the body. Recent studies ...

3. withpower.com withpower.com/trial/early-phase-1-head-and-neck-neoplasms-2-2010-36c4a

Smoking Cessation Treatment for Head & Neck Cancer ... Research shows that Acceptance and Commitment Therapy (ACT) can help people quit smoking, as seen in studies where it was delivered via phone or online.

4. jmir.org jmir.org/2022/3/e27588/

Health Economic Evaluation and Outcomes of a Pragmatic ... This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001039

Efficacy of smartphone applications to help cancer patients ... The trial will also determine whether Quit2Heal's effect on cessation is (1) mediated by improvements in cancer-related shame, stigma, depression, anxiety, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9743826/

Current Status and Future Trends of Acceptance ... Results showed that EA was negatively associated with internal discomfortness on smoking cessation. However, ACT improved mental adaptability by helping ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK583422/

Treating Tobacco Use and Dependence in Cancer Populations A meta-analysis of 4 RCTs– indicated significant benefits on long-term abstinence, with a near doubling of the quit rates (i.e., 25.2% vs. 13.6%). A second meta ...