Smoking Cessation Support for Cervical Cancer Survivors

Recruiting in Palo Alto (17 mi)

Overseen by Jennifer Vidrine, PhD, MS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Tobacco treatment, Household member enrolled

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new way to help people who have had cervical cancer or severe cervical issues quit smoking. The treatment includes motivational phone calls and personalized text messages. These methods aim to provide support and practical tips to make quitting smoking easier. Research has found that text messaging is effective for helping people quit smoking.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already receiving any tobacco treatment, either behavioral or with medication.

What data supports the effectiveness of the Motivation and Problem Solving (MAPS) treatment for smoking cessation in cervical cancer survivors?

Research shows that the MAPS treatment, which includes counseling and nicotine replacement therapy, led to a more than two-fold increase in smoking abstinence at 12 months compared to a standard quitline control group, although the effect decreased over time. ^{1 2 3 4 5}

Is the Smoking Cessation Support for Cervical Cancer Survivors treatment safe for humans?

The treatments involved, such as the Motivation and Problem Solving (MAPS) intervention and Nicotine Replacement Therapy (NRT) like nicotine lozenges and patches, have been used safely in various populations, including those with mental health conditions, through quitline services. These treatments are generally considered safe for helping people quit smoking. ^{1 6 7 8 9}

How is the MAPS treatment for smoking cessation in cervical cancer survivors different from other treatments?

The MAPS treatment is unique because it combines cognitive behavioral strategies with a motivational framework, making it suitable for all smokers regardless of their motivation to quit. It includes phone counseling and a digital component to support long-term abstinence, specifically tailored for cervical cancer survivors. ^{2 3 4 5 10}

Research Team

Jennifer Vidrine, PhD, MS

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals in Florida who have a history of cervical cancer or high-grade cervical dysplasia, currently smoke cigarettes, and have smoked at least 100 in their lifetime. They must speak English and own a working smartphone. People can't join if they live with someone already enrolled, cannot use nicotine replacement due to medical reasons, or are undergoing other tobacco treatments.

Inclusion Criteria

Currently smoke 1 cigarette or more in the past 30 days

Has a valid home address

I have had cervical cancer or severe cervical pre-cancer.

Exclusion Criteria

Household member enrolled in this study

I am currently getting treatment to help me stop smoking.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week supply of nicotine replacement therapy and MAPS intervention, including 6 counseling calls over 12 months and tailored SMS content for 24 months

24 months

6 counseling calls, monthly smartphone check-ins

Follow-up

Participants are monitored for smoking abstinence and effectiveness of the treatment

24 months

Treatment Details

Interventions

• Motivation and Problem Solving (MAPS) intervention (Behavioural Intervention)
• Nicotine Lozenge (Nicotine Replacement Therapy)
• Nicotine patch (Nicotine Replacement Therapy)
• Smoking Cessation treatment delivered by Tobacco Free Florida Quitline (Behavioural Intervention)

Trial Overview The study tests the effectiveness of combining MAPS-based telephone counseling with tailored text messages versus standard quitline smoking cessation treatment. Participants will receive either nicotine patches or lozenges as part of their therapy.

Participant Groups

Group I: Group 2: Motivation and Problem Solving (MAPS) counseling Experimental Treatment 3 Interventions

Participants will receive a 12 week supply of nicotine replacement therapy (the patch and lozenges) along with the MAPS intervention, which consists of 6 MAPS counseling calls over 12 months, and individually tailored SMS text content driven by monthly smartphone delivered check-ins for 24 months

Group II: Group 1: Standard Treatment Active Control 3 Interventions

Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Patrick Hwu

H. Lee Moffitt Cancer Center and Research Institute

Chief Executive Officer since 2020

MD from The Medical College of Pennsylvania

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

James and Esther King Biomedical Research Program

Collaborator

Trials

15

Recruited

2,200+

Findings from Research

The study involved 603 low socioeconomic status smokers and found that the Motivation And Problem Solving (MAPS) counseling approach significantly increased enrollment in Quitline services compared to standard treatment.

The provision of Nicotine Replacement Therapy (NRT) did not enhance Quitline enrollment, suggesting that the MAPS intervention alone is effective in reaching underserved populations for tobacco cessation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial. Vinci, C., Lam, C., Schlechter, CR., et al.[2022]

The MAPS intervention significantly increased smoking abstinence rates among women with a history of cervical intraepithelial neoplasia or cervical cancer at 12 months, achieving 26.4% abstinence compared to 11.9% in the standard treatment group.

At 18 months, the difference in abstinence rates between MAPS and standard treatment was no longer significant, indicating that while MAPS was effective in the short term, its long-term efficacy may need further support to maintain smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial. Vidrine, JI., Sutton, SK., Wetter, DW., et al.[2023]

A randomized clinical trial involving 202 cervical cancer survivors is evaluating the efficacy of the MAPS approach for smoking cessation, which includes proactive counseling and standard treatment components over 12 months.

The study aims to determine if the MAPS intervention is more effective than standard treatment in helping these women quit smoking, with significant public health implications if proven successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. Jones, SR., Vidrine, DJ., Wetter, DW., et al.[2022]

A randomized clinical trial is underway to evaluate the effectiveness of a novel SMS-delivered digital treatment (MAPS+) combined with a phone counseling approach for smoking cessation among 340 cervical cancer survivors, building on previous findings that showed MAPS doubled smoking abstinence rates at 12 months.

The study aims to determine if the addition of a 24-month digital treatment can enhance long-term smoking cessation success compared to standard treatment, which could have significant implications for public health and support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing long-term smoking abstinence among individuals with a history of cervical intraepithelial neoplasia or cervical cancer (Project ACCESS): protocol for a randomized clinical trial. Vidrine, JI., Fennell, BS., Simmons, VN., et al.[2023]

Cervical cancer survivors from low socioeconomic backgrounds often do not recognize the link between smoking and their cancer, believing their diagnosis is solely due to human papillomavirus, indicating a need for targeted education in cessation programs.

Participants emphasized the importance of a supportive and nonjudgmental approach in smoking cessation treatment, suggesting that effective programs should include psychoeducation, coping strategies, and address stress management and lifestyle changes specific to their survivorship experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Treatment Needs of Low SES Cervical Cancer Survivors. Hoover, DS., Spears, CA., Vidrine, DJ., et al.[2023]

Among 10,720 participants using a state quitline, 19.8% reported having mental health conditions (MHC), and those with MHC had lower quit rates (16.4%) compared to those without MHC (21.5%).

Participants with MHC were found to be 23% less likely to quit smoking, indicating that while quitline services are utilized by this population, additional support may be necessary to improve their cessation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cessation among state quitline participants with a mental health condition. Kerkvliet, JL., Wey, H., Fahrenwald, NL.[2018]

The implementation of a new model for QUITPLAN Services in Minnesota, which offered more choices and reduced registration barriers, led to a 169% increase in registrations among tobacco users, reaching 15,861 participants in just one year.

The program resulted in high quit attempt rates (83.7%) and a 30-day abstinence rate of 26.1%, demonstrating that providing diverse cessation options can effectively engage smokers and improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing reach by offering choices: Results from an innovative model for statewide services for smoking cessation. Keller, PA., Schillo, BA., Kerr, AN., et al.[2018]

Participants in the South Dakota QuitLine who received coaching along with varenicline had the highest abstinence rate at 49.8%, compared to lower rates for other service combinations, indicating that this combination is particularly effective for quitting tobacco.

Overall, the study found that all cessation services offered by the QuitLine resulted in abstinence rates of 40% or greater, demonstrating the effectiveness of these support options for tobacco users motivated to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco quitline outcomes by service type. Kerkvliet, JL., Fahrenwald, NL.[2018]

A study involving 2,041 participants showed that a telephone-based smoking cessation program (quitline) significantly reduced the number of cigarettes smoked per day, indicating its effectiveness in promoting smoking cessation.

The analysis found that missing data did not systematically affect the outcomes of cigarette reduction, suggesting that the quitline's efficacy is robust even when some participants miss calls, and highlights the importance of considering nicotine dependence in evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of cigarettes per day during the course of telephone tobacco cessation counseling services: a comparison of missing data models. Witkiewitz, K., Bush, T., Magnusson, LB., et al.[2018]

A motivationally tailored phone counseling program for female smokers at risk for cervical cancer was well accepted, with 79% enrollment and 90% completion of calls, regardless of their initial motivation to quit smoking.

Participants receiving the counseling had a higher 7-day point-prevalence abstinence rate at 6 months (20% vs. 12% for usual care), indicating that the intervention effectively encouraged smoking cessation, although the difference in abstinence rates diminished by 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive, motivationally enhanced smoking cessation counseling among women with elevated cervical cancer risk. McClure, JB., Westbrook, E., Curry, SJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial. [2022]

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

Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. [2022]

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

Enhancing long-term smoking abstinence among individuals with a history of cervical intraepithelial neoplasia or cervical cancer (Project ACCESS): protocol for a randomized clinical trial. [2023]

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

Smoking Cessation Treatment Needs of Low SES Cervical Cancer Survivors. [2023]

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

Cessation among state quitline participants with a mental health condition. [2018]

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

Increasing reach by offering choices: Results from an innovative model for statewide services for smoking cessation. [2018]

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

Tobacco quitline outcomes by service type. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Trajectories of cigarettes per day during the course of telephone tobacco cessation counseling services: a comparison of missing data models. [2018]

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

Proactive, motivationally enhanced smoking cessation counseling among women with elevated cervical cancer risk. [2022]