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Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients

Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909357
Acronym
Project mFLi
Enrollment
38
Registered
2025-04-03
Start date
2025-03-28
Completion date
2026-08-26
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

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.

Interventions

OTHERQuitline Treatment (QT)

Tobacco Free Florida Quitline. 10-week supply of Combination Nicotine Replacement Therapy (NRT).

OTHERApp-based Treatment (mHealth)

Fully automated digitally-delivered smoking cessation intervention targeted to cancer patients. 10-week supply of Combination Nicotine Replacement Therapy (NRT).

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
Florida Biomedical Research Program - James & Esther King
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: ScreeningAt BaselineOur 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.
Usability: mHealthUp to 6 MonthsUsability 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).
Acceptability/Satisfaction: mHealthUp to 6 MonthsAcceptability/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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDamon Vidrine, DrPH

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORVani Simmons, PhD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026