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

Not Applicable

Recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT06909357
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Study First Posted: 2025-04-03
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-06-01
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Feasibility: Screening	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.
Usability: mHealth	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).
Acceptability/Satisfaction: mHealth	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.

Trial Locations

Locations (3)

University of Miami; 🇺🇸 Coral Gables, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States