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OpenTrials
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NCT Number: NCT06909357

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quitline Treatment (QT)

Other

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

App-based Treatment (mHealth)

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Biomedical Research Program - James & Esther King

Registry information

Official study title

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

Acronym: Project mFLi

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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