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Trial Title:
Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
NCT ID:
NCT05579847
Condition:
Renal Cell Carcinoma Stage IV
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
Kidney cancer
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
mHealth Smart Phone Application
Description:
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.
Arm group label:
Study Participants
Intervention type:
Behavioral
Intervention name:
eHEALS digital literacy test
Description:
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.
Arm group label:
Study Participants
Intervention type:
Behavioral
Intervention name:
Weekly Quiz
Description:
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.
Arm group label:
Study Participants
Intervention type:
Behavioral
Intervention name:
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Description:
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).
Arm group label:
Study Participants
Intervention type:
Behavioral
Intervention name:
Patient Post Intervention Survey
Description:
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.
Arm group label:
Study Participants
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.
Criteria for eligibility:
Study pop:
Patients at the genitourinary medical oncology clinic at Moffitt Cancer Center with Stage
IV Renal Cell Carcinoma.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Start date:
October 19, 2022
Completion date:
January 7, 2025
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05579847
https://www.moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE
