Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients (Project mFLi)

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Other: Quitline Treatment (QT); Other: App-based Treatment (mHealth)

Study type: Interventional

Funder types: Other

Identifiers

NCT06909357

MCC-23179

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Demonstration Project 1

No Intervention group

Description:

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.

Demonstration Project 2

Experimental group

Description:

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.

Treatment:

Other: App-based Treatment (mHealth)

Other: Quitline Treatment (QT)

Demonstration Project 3

No Intervention group

Description:

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.