Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
NCT ID: NCT05579847
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2022-10-19
2024-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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).
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.
Interventions
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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.
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.
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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Enrolled in another clinical trial
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Jad Chahoud, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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References
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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.
Related Links
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Moffitt Cancer Center Clinical Trials website
Other Identifiers
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MCC-21569
Identifier Type: -
Identifier Source: org_study_id
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