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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age.

≥100 lifetime cigarettes.

English-speaking.

Report smoking ≥ 1 cigarette in past 30 days.

Disqualifiers

Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.

Currently pregnant or breastfeeding.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Quitline Treatment (QT)

    Other intervention

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

  • App-based Treatment (mHealth)

    Other intervention

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Demonstration Project 1No intervention 0 interventions
Group B: Demonstration Project 2Experimental treatment 2 interventions
Group C: Demonstration Project 3No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At Baseline
2

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).

Time frame
Up to 6 Months
3

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.

Time frame
Up to 6 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Florida Biomedical Research Program - James & Esther King

Collaborator