A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
Interventional
Phase not listed
MD Anderson Cancer Center
To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.
Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.
* Part 1 (Run-in Phase): Only patients with prostate, kidney, and/or bladder cancer will be enrolled with either localized or metastatic disease.
* Part 2 (Expansion Phase): Metastatic patients will be enrolled. Note, evaluable metastatic patients from Ppart 1 will be counted in Cohort A as described in section 8.4.
* Planned to receive systemic anti-cancer therapy
* Ability to understand and the willingness to sign a written informed consent document
* Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese
* Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF
Exclusion Criteria
- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).
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Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll425
Arms & Interventions
Arms
Interventions
Type: Other
Description: Participants will have 24/7 access to the ApricityCare service. Participants can check in and report any symptoms or side effects through the ApricityCare app, or by phone, at any time.
Participants will be asked to report your status at least weekly, even if participants are not experiencing any side effects. ApricityCare nurses will review each participants report and provide appropriate education and/or virtual management or escalate, as needed, to the study doctor or emergency service, based on guidelines. Each encounter with an ApricityCare nurse will be sent to the electronic health record (EHR) in real time for review/inclusion into your medical record.
For any in-person visits participants attend, the study doctor will review the ApricityCare symptom summary with participants. For all these visits, please bring your smartphone, which carries the ApricityCare application, for this review.
Interventions:
Metastatic Cancer
Outcome Measures
Primary Outcome Measures
Safety and Adverse EventsThrough study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Secondary Outcome Measures
None
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