What is the mechanism of action of this treatment?

The most common treatments for cervical cancer include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissue, which is crucial for localized tumors. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors, often used in conjunction with surgery or for inoperable cases. Chemotherapy employs drugs to destroy cancer cells, typically used for advanced stages or when cancer has spread. Understanding these mechanisms is vital for cervical cancer patients as it helps them comprehend the rationale behind their treatment plans, manage expectations, and adhere to prescribed therapies. Behavioral support and personalized motivation, such as MAPS-based telephone counseling and SMS-delivered text-based approaches, can enhance treatment adherence and emotional well-being by providing tailored guidance and encouragement throughout the treatment journey.

What side effects are associated with this type of intervention?

Common treatments for cervical cancer include surgery, radiation therapy, chemotherapy, and targeted therapy. Side effects of these treatments can vary but often include fatigue, nausea, vomiting, diarrhea, and skin changes. Radiation therapy may cause localized skin irritation and changes in bowel or bladder habits. Chemotherapy can lead to hair loss, increased risk of infection, and neuropathy. Behavioral support and personalized motivation treatments, such as MAPS-based telephone counseling and SMS-delivered text-based approaches, generally have minimal physical side effects but may include emotional or psychological responses such as anxiety or frustration if progress is slow.

What prior FDA approvals exist?

FDA approvals for the treatment of cervical cancer have primarily focused on medical and surgical interventions, including chemotherapy, radiation therapy, and immunotherapy. While there is no specific mention of FDA-approved treatments involving behavioral support or personalized motivation like MAPS-based telephone counseling and SMS-delivered text-based approaches, these methods are being studied to enhance smoking cessation among cervical cancer survivors. Broadly, the FDA has approved drugs such as pembrolizumab (Keytruda) for advanced cervical cancer, which targets the PD-1/PD-L1 pathway to help the immune system fight cancer cells.

What other types of research exist?

Promising alternatives to MAPS-based telephone counseling and SMS-delivered text-based approaches for cervical cancer patients include: 1) Mobile health applications that offer real-time monitoring and personalized feedback, 2) Telemedicine platforms providing remote consultations and continuous support, and 3) Internet-based guided self-help programs that incorporate cognitive-behavioral therapy principles and regular digital interactions with healthcare providers.

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Smoking Cessation Support for Cervical Cancer Survivors

N/A

Recruiting

Led By Jennifer Vidrine, PhD, MS

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the interventions may include skin irritation from nicotine patches, mouth problems like soreness or hiccups from lozenges, and possible withdrawal symptoms such as irritability, cravings, or difficulty concentrating when quitting smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MAPS vs Standard Treatment in facilitating long term smoking abstinence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: Motivation and Problem Solving (MAPS) counselingExperimental Treatment3 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 TreatmentActive Control3 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine patch

2015

Completed Phase 4

~6130

Nicotine Lozenge

2005

Completed Phase 4

~300

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for cervical cancer include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissue, which is crucial for localized tumors. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors, often used in conjunction with surgery or for inoperable cases. Chemotherapy employs drugs to destroy cancer cells, typically used for advanced stages or when cancer has spread. Understanding these mechanisms is vital for cervical cancer patients as it helps them comprehend the rationale behind their treatment plans, manage expectations, and adhere to prescribed therapies. Behavioral support and personalized motivation, such as MAPS-based telephone counseling and SMS-delivered text-based approaches, can enhance treatment adherence and emotional well-being by providing tailored guidance and encouragement throughout the treatment journey.

Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.A guided self-help intervention targeting psychological distress among head and neck cancer and lung cancer patients: motivation to start, experiences and perceived outcomes.