Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients (Project mFLi)
July 7, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients.
Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy.
Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach.
The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients.
This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
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Gainesville, Florida, United States, 23611
- University of Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥18 years of age.
- ≥100 lifetime cigarettes.
- English-speaking.
- Report smoking ≥ 1 cigarette in past 30 days.
- Working smartphone.
Exclusion Criteria:
- Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
- Currently pregnant or breastfeeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Demonstration Project 1
Screening and recruitment of cancer patients for connection to evidence-based smoking cessation treatment.
The goal of the first demonstration project is to develop a feasible and effective method for screening cancer patients for smoking, determining treatment eligibility, and offering treatment.
|
|
|
Experimental: Demonstration Project 2
Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients.
The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial.
|
Tobacco Free Florida Quitline.
10-week supply of Combination Nicotine Replacement Therapy (NRT).
Fully automated digitally-delivered smoking cessation intervention targeted to cancer patients.
10-week supply of Combination Nicotine Replacement Therapy (NRT).
|
|
No Intervention: Demonstration Project 3
Utilizing machine learning to process data obtained from demonstration projects 1 and 2. In Demonstration Project 3, we will utilize all data collected in Demonstration Projects 1 and 2 to conduct machine and deep learning methods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Screening
Time Frame: At Baseline
|
Our screening process will be deemed feasible if: 1) ≥ 90% of patients complete the screener, 2) the proportion of patients identified as smokers meets or exceeds the historical self-reported proportions at each institution, 3) the program correctly identifies eligible participants and subsequently presents automated advice to quit, 4) it offers an opportunity to enroll in smoking cessation treatment, and 5) ≥ 30% of eligible patients enroll in treatment.
|
At Baseline
|
|
Usability: mHealth
Time Frame: Up to 6 Months
|
Usability will be measured 2 ways: I) ≥ 80% will score ≥ 70 on the Systems Usability Scale (SUS), 10-item measure, (scores 0-100) assessing learnability and usability.
II) ≥ 80% rate app as easy to use (dichotomous Y/N).
|
Up to 6 Months
|
|
Acceptability/Satisfaction: mHealth
Time Frame: Up to 6 Months
|
Acceptability/Satisfaction will be measured 4 ways: I) ≥ 80 will score mean ≥ 3.0 Client Satisfaction Questionnaire (CSQ), 8-item measure, (1-4 scale).
II) ≥ 80% mostly or extremely satisfied with app.
III) ≥ 80% would recommend this app to a friend to quit smoking (dichotomous Y/N).
IV) ≥ 80% rate quality of intervention as good or excellent.
|
Up to 6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Damon Vidrine, DrPH, Moffitt Cancer Center
- Principal Investigator: Vani Simmons, PhD, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
March 27, 2025
First Submitted That Met QC Criteria
March 27, 2025
First Posted (Actual)
April 3, 2025
Study Record Updates
Last Update Posted (Actual)
July 8, 2026
Last Update Submitted That Met QC Criteria
July 7, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-23179
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.