Smoking CessationNCT05645146
Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
A study testing Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Nicotine patch and Nicotine Lozenge in people with Smoking Cessation and Cervical Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Cervical Cancer, High Grade Cervical Dysplasia
- What is being tested?
- Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Nicotine patch and Nicotine Lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 100 cigarettes or more smoked in participants lifetime
- Speaks English
- Currently smoke 1 cigarette or more in the past 30 days
- History of cervical cancer or high grade cervical dysplasia
- Has a working smartphone
- Has a valid home address
- Reside in Florida at the time of study enrollment
Who cannot join
- Receiving behavioral or pharmacological tobacco treatment
- Household member enrolled in this study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
- Being tested
- Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Nicotine patch, Nicotine Lozenge, Motivation and Problem Solving (MAPS) intervention
- Medical subject headings
- Smoking Cessation, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation treatment delivered by Tobacco Free Florida QuitlineBehavioural
Phone counseling with the state tobacco quitline
Nicotine patchDrug
Participants will be provided with a 12 week supply of nicotine patches
Nicotine LozengeDrug
Participants will be provided with a 12 week supply of nicotine lozenges
Motivation and Problem Solving (MAPS) interventionBehavioural
MAPS is a phone counseling approach to facilitating smoking cessation among cervical cancer survivors, which uses a combined motivational interviewing and social cognitive theory based approach to smoking cessation. Participants will receive 6 MAPS based counseling calls over 12 months, along with personally-tailored SMS-delivered text based messages delivered to the participants phone over 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard Treatment | Active comparator | Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges) Receives: Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline; Drug: Nicotine patch; Drug: Nicotine Lozenge |
| Group 2: Motivation and Problem Solving (MAPS) counseling | Experimental | 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 Receives: Drug: Nicotine patch; Drug: Nicotine Lozenge; Behavioral: Motivation and Problem Solving (MAPS) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAPS vs Standard Treatment in facilitating long term smoking abstinence
The primary outcome of this study is self-reported, 7 day point prevalence abstinence over time through the 24 month assessment where participants who report no smoking in the previous 7 days at follow-up assessment are considered abstinent.
Efficacy of MAPS vs Standard Treatment will be measured by comparing the number of participants in each group who were able to quit smoking and maintain smoking abstinence for 2 years.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start29 Nov 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Sponsor
- Investigators
- Jennifer Vidrine, PhD, MS, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645146
- Sponsor's protocol ID
- MCC-21885
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vidrine JI, Fennell BS, Simmons VN, Sutton SK, Jones SR, Woodward HW, Hoogland CE, Vidrine DJ. 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. BMC Public Health. 2023 Jul 4;23(1):1284. doi: 10.1186/s12889-023-16189-3.
PubMed 37403057
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
- ClinicalTrials.gov ID
- NCT05645146
- Acronym / sponsor ID
- MCC-21885
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard Treatment | Active comparator | Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Drug: Nicotine patch, Drug: Nicotine LozengeParticipants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges) |
| Group 2: Motivation and Problem Solving (MAPS) counseling | Experimental | Drug: Nicotine patch, Drug: Nicotine Lozenge, Behavioral: Motivation and Problem Solving (MAPS) interventionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 100 cigarettes or more smoked in participants lifetime
- Speaks English
- Currently smoke 1 cigarette or more in the past 30 days
- History of cervical cancer or high grade cervical dysplasia
- Has a working smartphone
Key exclusion criteria (2 listed)
- Receiving behavioral or pharmacological tobacco treatment
- Household member enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation treatment delivered by Tobacco Free Florida QuitlinePhone counseling with the state tobacco quitline | Behavioural | Group 1: Standard Treatment |
| Nicotine patchParticipants will be provided with a 12 week supply of nicotine patches | Drug | Group 1: Standard Treatment, Group 2: Motivation and Problem Solving (MAPS) counseling |
| Nicotine LozengeParticipants will be provided with a 12 week supply of nicotine lozenges | Drug | Group 1: Standard Treatment, Group 2: Motivation and Problem Solving (MAPS) counseling |
| Motivation and Problem Solving (MAPS) interventionMAPS is a phone counseling approach to facilitating smoking cessation among cervical cancer survivors, which uses a combined motivational interviewing and social cognitive theory based approach to smoking cessation. Participants will receive 6 MAPS based counseling calls over 12 months, along with personally-tailored SMS-delivered text based messages delivered to the participants phone over 2 years. | Behavioural | Group 2: Motivation and Problem Solving (MAPS) counseling |
Primary outcome
MAPS vs Standard Treatment in facilitating long term smoking abstinence
Time frame: at 24 months
The primary outcome of this study is self-reported, 7 day point prevalence abstinence over time through the 24 month assessment where participants who report no smoking in the previous 7 days at follow-up assessment are considered abstinent. Efficacy of MAPS vs Standard Treatment will be measured by comparing the number of participants in each group who were able to quit smoking and maintain smoking abstinence for 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 37403057Vidrine JI, Fennell BS, Simmons VN, Sutton SK, Jones SR, Woodward HW, Hoogland CE, Vidrine DJ. 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. BMC Public Health. 2023 Jul 4;23(1):1284. doi: 10.1186/s12889-023-16189-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Vidrine, PhD, MS principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Nicotine patch and Nicotine Lozenge in people with Smoking Cessation and Cervical Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAPS vs Standard Treatment in facilitating long term smoking abstinence (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.