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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-28

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Quitline Treatment (QT)

Intervention Type OTHER

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

App-based Treatment (mHealth)

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Quitline Treatment (QT)

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

Intervention Type OTHER

App-based Treatment (mHealth)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No