This clinical trial evaluates a symptom monitoring service called the Apricity Cancer Adverse Events Rapid Evaluation (CARE) program for early detection and management of treatment-related adverse events in patients with prostate, kidney or bladder cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to other places in the body (metastatic). ApricityCare is a software application that educates patients about side effects, reminds patients to self-report any side effects, and provides remote clinical support delivered by registered nurses trained to monitor, triage, and manage common cancer symptoms and immune-related adverse events (irAEs). Researchers want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06693687.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Bilal Ahmed Siddiqui
PRIMARY OBJECTIVES:
I. To determine the feasibility of patient symptom reporting via ApricityCare. (Run-in Phase [Part 1])
II. To determine the rate of therapy discontinuation due to toxicity in patients using ApricityCare. (Expansion Phase [Part 2])
SECONDARY OBJECTIVES:
I. To measure frequency of patient check-in via ApricityCare to report symptoms. (Expansion Phase [Part 2])
II. To assess patient engagement with ApricityCare. (Expansion Phase [Part 2])
III. To evaluate time to respond to patient-reported symptoms via ApricityCare. (Expansion Phase [Part 2]) (in cohort A only)
EXPLORATORY OBJECTIVES:
I. To correlate self-reported immune-related adverse events (irAEs) detected via ApricityCare with clinical diagnosis of irAEs. (Expansion Phase [Part 2]) (in cohort A only)
II. To determine prevalence of high-dose corticosteroid use in patients with immune toxicities who use ApricityCare. (Expansion Phase [Part 2]) (in cohort A only)
III. To evaluate utilization of acute and emergency care services in patients using ApricityCare. (Expansion Phase [Part 2]) (in cohort A only)
OUTLINE:
Patients use the ApricityCARE mobile application at least once a week on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBilal Ahmed Siddiqui