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

Active, not recruiting

• Conditions: Renal Cell Carcinoma Stage IV
• Interventions: Other: mHealth Smart Phone Application; Behavioral: eHEALS digital literacy test; Behavioral: Weekly Quiz; Behavioral: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire; Behavioral: Patient Post Intervention Survey

• Registration Number: NCT05579847
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Study Start: 2022-10-19
• Primary Completion: 2024-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Participants	Weekly Quiz	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.
Study Participants	eHEALS digital literacy test	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.
Study Participants	mHealth Smart Phone Application	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.
Study Participants	Patient Post Intervention Survey	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.
Study Participants	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of Smart Phone Application	at 6 months	Patient's acceptability of the smart phone application for education will be captured in the patient post education survey.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Smart Phone Application -Quality of Life	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.
Efficacy of Smart Phone Application - Patient Knowledge	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States