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

51 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for smoking cessation in head and neck cancer patients?

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. Additionally, ACT has been effective in improving psychological well-being in head and neck cancer patients, which may support its use in helping these patients quit smoking. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) has been studied in various contexts, including for smoking cessation and improving quality of life in cancer patients, and is generally considered safe for humans. ^{1 2 3 6 7}

How is Acceptance and Commitment Therapy (ACT) different from other smoking cessation treatments for head and neck cancer patients?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping patients accept their thoughts and feelings rather than trying to change them, and it encourages commitment to personal values as a way to motivate behavior change. This approach is different from traditional smoking cessation methods that often focus on directly changing behavior or using medications. ^{5 8 9 10 11}

What is the purpose of this trial?

This is Part 1 of a 2-part research study. 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 have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer. This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy. In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling. This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy. The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.

Research Team

Jan Blalock, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Acceptance and commitment therapy versus mindfulness-based stress reduction for newly diagnosed head and neck cancer patients: A randomized controlled trial assessing efficacy for positive psychology, depression, anxiety, and quality of life. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Randomized trial of telephone-delivered acceptance and commitment therapy versus cognitive behavioral therapy for smoking cessation: a pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Immediate, Short-term, Medium-term, and Long-term effects of Acceptance and Commitment Therapy for Smoking Cessation: a systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of web-based acceptance and commitment therapy for smoking cessation. [2022]

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

Smoking cessation for patients with head and neck cancer: a qualitative study of patients' and nurses' experiences in a nurse-led intervention. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. [2022]

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

Counseling Is Effective for Smoking Cessation in Head and Neck Cancer Patients-A Systematic Review and Meta-Analysis. [2018]

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

Predictors of long-term smoking cessation in head and neck cancer patients. [2022]

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

Impact of a tobacco treatment program on abstinence and survival rates among current smokers with head and neck squamous cell carcinoma. [2023]

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

"Cold turkey" or pharmacotherapy: Examination of tobacco cessation methods tried among smokers prior to developing head and neck cancer. [2020]