NCT05579847

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma Stage IV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-19
• Primary completion: 2024-01-07
• Completion: 2024-11-04
• First posted: 2022-10-14
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States