Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy

December 3, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute

The Feasibility of an Educational and Monitoring Smart-Phone Application for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy

The purpose of the study is to test and understand acceptability and preliminary effectiveness of a mobile educational app specifically customized to patients with advanced Renal Cell Carcinoma (RCC) receiving therapy with combination immunotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at the genitourinary medical oncology clinic at Moffitt Cancer Center with Stage IV Renal Cell Carcinoma.

Description

Inclusion Criteria:

  • Patients with Stage IV Renal Cell Carcinoma
  • Within 3 weeks from starting combination immune checkpoint blockade with tyrosine kinase inhibitor or multikinase inhibitor
  • Estimated survival of 6 months or more
  • Able to read and speak English

Exclusion Criteria:

  • Unable to read or speak English
  • Enrolled in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Participants
Participants with Stage IV Renal Cell Carcinoma will be recruited in the genitourinary medical oncology clinic at Moffitt Cancer Center. Upon consenting, participants will be provided with an mHealth interactive smart phone application.
Other: mHealth Smart Phone Application
The mHealth interactive application consists of educational intervention geared towards eligible patients who are receiving Nivolumab/ Pembro with Axitinib/Cabozantinib/Lenvatinib. These patients commonly experience immune-related side effects, higher rate of fatigue, high blood pressure, and palmar-plantar erythrodysesthesia. The educational intervention will consist of multiple modules covering relevant information on treatment and adverse events and provided over a six-week period through an mHealth platform. This educational intervention includes a patient-friendly algorithm for early detection and management of the most common adverse events in patients with advanced renal cell carcinoma receiving combination immunotherapy.
Behavioral: eHEALS digital literacy test
The eHEALS digital literacy test is an 8-item measure of eHealth literacy developed to measure the participants combined knowledge, comfort and perceived skills at finding, evaluating and applying electronic health information to health problems. The test is measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.
Behavioral: Weekly Quiz
Participants will take a weekly true/false quiz to assess knowledge of their diagnosis, expected outcome and treatment associated adverse effects at baseline and longitudinally. Each quiz will be administered at the beginning of the week before the weekly educational content is available, then the same quiz will be administered after the educational content is reviewed by the patient. Each quiz will be scored based on the number of correct answers.
Behavioral: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) comprises 30 single questions, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact) scales assess symptoms. No item occurs in more than one scale.

Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

Behavioral: Patient Post Intervention Survey
The Patient Post Intervention Survey is a 7 question survey to help determine the effectiveness of the mHealth app. 3 questions are open fields for patient feedback, and 4 questions ask how often the app was used, how often the educational module was used and if the patient found it useful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Smart Phone Application
Time Frame: at 6 months
Patient's acceptability of the smart phone application for education will be captured in the patient post education survey.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Smart Phone Application -Quality of Life
Time Frame: at 6 months
Efficacy of the smart phone application on patient quality of life will be assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scores.
at 6 months
Efficacy of Smart Phone Application - Patient Knowledge
Time Frame: Weekly, beginning at baseline to month 6
Efficacy of the smart phone application on patient knowledge of their diagnosis and treatment will be assessed by weekly true/false quizzes.
Weekly, beginning at baseline to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Pfizer

Investigators

  • Principal Investigator: Jad Chahoud, MD, MPH, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

January 7, 2024

Study Completion (Actual)

November 4, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-21569

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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