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

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06909357
Status
Recruiting
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Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Mar 28, 2025
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Feasibility: Screening [ Time Frame: At Baseline ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Tracey Crane, PhD, RDN (SUB_INVESTIGATOR)
Taghrid Asfar, MD (SUB_INVESTIGATOR)
Frank Penedo, PhD (SUB_INVESTIGATOR)
University of FloridaGainesvilleFlorida23611
Jesse Dallery, PhD (SUB_INVESTIGATOR)
Ramzi Salloum, PhD, MA, MBA (SUB_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Coral Gables, FL

By research site
University of Miami· Coral Gables, FLUniversity of Florida· Gainesville, FLMoffitt Cancer Center· Tampa, FL

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