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. 2024 Jul:8:e2400044.
doi: 10.1200/CCI.24.00044.

Feasibility of a Smartphone Application for Education and Symptom Management of Patients With Renal Cell Carcinoma on Combined Tyrosine Kinase and Immune Checkpoint Inhibitors

Gabriel Roman Souza  1   2 , Kea Turner  3 , Keerthi Gullapalli  1   2 , Mahati Paravathaneni  1   2 , Filip Ionescu  1   2 , Adele Semaan  4 , Amayla Budet DeJesus  5 , Gillian Trujillo  5 , Casey Le  3 , Youngchul Kim  6 , Xiaoqi Sun  6 , Sarah Raymond  2 , Amy Schneider  7 , Brandon Manley  2 , Rohit Jain  2 , Scott Gilbert  2 , Heather S L Jim  3 , Philippe E Spiess  2 , Jad Chahoud  2
Affiliations

Feasibility of a Smartphone Application for Education and Symptom Management of Patients With Renal Cell Carcinoma on Combined Tyrosine Kinase and Immune Checkpoint Inhibitors

Gabriel Roman Souza et al. JCO Clin Cancer Inform. 2024 Jul.

Abstract

Purpose: Patients with advanced renal cell carcinoma (RCC) face significant challenges, stemming both from the complexities of the disease itself and the adverse effects of treatments. This study evaluated the feasibility and acceptability of a mobile health (mHealth) application tailored for education and symptom management of patients with advanced RCC receiving combined immune checkpoint inhibitor and tyrosine kinase inhibitor (ICI-TKI) therapy.

Methods: The primary end points were acceptability and feasibility. Acceptability was defined as the proportion of patients approached who consented to participate, setting a benchmark of at least 50% for this metric. Feasibility was gauged by the completion rate of the intervention among the participants; it required at least 50% of participants to fully complete the intervention and at least 70% to finish half of the administered questionnaires. The secondary end points included knowledge assessment and patient-reported outcomes (PROs). PROs were evaluated using validated instruments. To discern the changes between pre- and post-educational module quiz scores, we used the Wilcoxon signed-rank test. Time-course data of PROs were visualized using line plots and then compared using paired t-tests.

Results: From November 2022 to July 2023, 20 of 22 (90%) patients approached for the study consented and enrolled. Of the enrolled patients, 60% completed all questionnaires and knowledge assessments at every time point and 75% completed at least half of the surveys and questionnaires. Significant pre/post differences were noted in two of six quizzes in the knowledge assessment. This study population did not experience a significant change in PRO scores after starting therapy.

Conclusion: The mHealth application designed for education and symptom management in patients with advanced RCC undergoing combination ICI-TKI has proven to be both acceptable and feasible, meeting previous research benchmarks.

Trial registration: ClinicalTrials.gov NCT05579847.

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Conflict of interest statement

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/cci/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Adele Semaan

Consulting or Advisory Role: MyCareGorithm (I)

Gillian Trujillo

Employment: Moffitt Cancer Center (I)

Casey Le

Employment: Moffitt Cancer Center

Sarah Raymond

Honoraria: Total Health Conferencing

Amy Schneider

Consulting or Advisory Role: Bristol Myers Squibb Foundation

Brandon Manley

Consulting or Advisory Role: Merck

Patents, Royalties, Other Intellectual Property: EGFR splice variant as a biomarker in renal cancer (Inst)

Expert Testimony: Arnold & Porter

Rohit Jain

Honoraria: DAVA Oncology, Curio Science, FLASCO, MJH Life Sciences

Consulting or Advisory Role: Gilead Sciences, EMD Serono, Bristol Myers Squibb, AVEO, Sanofi

Speakers’ Bureau: Seattle Genetics/Astellas

Research Funding: Bristol Myers Squibb, Gilead Sciences, NCI

Travel, Accommodations, Expenses: DAVA Oncology, FLASCO, Sanofi

Heather S.L. Jim

Consulting or Advisory Role: SBR Bioscience

Research Funding: Kite, a Gilead company (Inst)

Patents, Royalties, Other Intellectual Property: Methods of Treating Cognitive Impairment, United States Letters Patent No. 10806772, 10/20/2020

Philippe E. Spiess

Leadership: NCCN, Global Society of Rare Genitourinary Tumors, Société Internationale d’Urologie Journal, President of Global Society of Rare GU Tumors

Honoraria: UptoDate

Other Relationship: NCCN

Uncompensated Relationships: Moffitt Cancer Center

Jad Chahoud

Consulting or Advisory Role: AVEO, DAVA Pharmaceuticals, Pfizer, Exelixis, Eisai, Merck

No other potential conflicts of interest were reported.

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