Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
The Feasibility of an Educational and Monitoring Smart-Phone Application for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2024
CompletedDecember 4, 2025
December 1, 2025
1.2 years
October 11, 2022
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability of Smart Phone Application
Patient's acceptability of the smart phone application for education will be captured in the patient post education survey.
at 6 months
Secondary Outcomes (2)
Efficacy of Smart Phone Application -Quality of Life
at 6 months
Efficacy of Smart Phone Application - Patient Knowledge
Weekly, beginning at baseline to month 6
Study Arms (1)
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.
Interventions
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.
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).
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.
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.
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.
Eligibility Criteria
Patients at the genitourinary medical oncology clinic at Moffitt Cancer Center with Stage IV Renal Cell Carcinoma.
You may qualify if:
- 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
You may not qualify if:
- Unable to read or speak English
- Enrolled in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizercollaborator
- H. Lee Moffitt Cancer Center and Research Institutelead
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (1)
Roman Souza G, Turner K, Gullapalli K, Paravathaneni M, Ionescu F, Semaan A, DeJesus AB, Trujillo G, Le C, Kim Y, Sun X, Raymond S, Schneider A, Manley B, Jain R, Gilbert S, Jim HSL, Spiess PE, Chahoud J. Feasibility of a Smartphone Application for Education and Symptom Management of Patients With Renal Cell Carcinoma on Combined Tyrosine Kinase and Immune Checkpoint Inhibitors. JCO Clin Cancer Inform. 2024 Jul;8:e2400044. doi: 10.1200/CCI.24.00044.
PMID: 39058967DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jad Chahoud, MD, MPH
Moffitt Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 14, 2022
Study Start
October 19, 2022
Primary Completion
January 7, 2024
Study Completion
November 4, 2024
Last Updated
December 4, 2025
Record last verified: 2025-12