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

NCT06909357 | Recruiting

• 1 other identifier: MCC-23179
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• Feasibility: Screening

  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.

  At Baseline

• Usability: mHealth

  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).

  Up to 6 Months

• Acceptability/Satisfaction: mHealth

  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.

  Up to 6 Months

Study Arms (3)

Demonstration Project 1

NO INTERVENTION

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

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.

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

Demonstration Project 3

NO INTERVENTION

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.

Interventions

Quitline Treatment (QT) OTHER

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

Demonstration Project 2

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).

Demonstration Project 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age.
• ≥100 lifetime cigarettes.
• English-speaking.
• Report smoking ≥ 1 cigarette in past 30 days.
• Working smartphone.

You may not qualify if:

• Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
• Currently pregnant or breastfeeding.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Florida Biomedical Research Program - James & Esther King: collaborator

Study Sites (3)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

University of Florida

Gainesville, Florida, 23611, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Damon Vidrine, DrPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Vani Simmons, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Jones

CONTACT

813-745-7525; Sarah.Jones@moffitt.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (3)