A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
NCT ID: NCT06693687
Last Updated: 2025-12-30
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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RECRUITING
NA
425 participants
INTERVENTIONAL
2024-12-18
2027-11-01
Brief Summary
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Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.
Detailed Description
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Secondary Objectives
• To evaluate time the ease and experience of patient use of ApricityCare (i.e., patient engagement) in reporting symptoms during their systemic cancer treatments. Furthermore, the frequency of patient symptom reporting via check-in to ApricityCare will be evaluated, as will the time taken to respond and engage patients after they report toxicity or other adverse events via ApricityCare.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Metastatic Cancer
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.
Metastatic Cancer
Participants will be asked to to take part in a research study because you have metastatic cancer (meaning that your cancer has spread to other parts of the body) and will be starting systemic therapy.
Interventions
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Metastatic Cancer
Participants will be asked to to take part in a research study because you have metastatic cancer (meaning that your cancer has spread to other parts of the body) and will be starting systemic therapy.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of cancer
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Bilal A Siddiqui, MD
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2024-09566
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0229
Identifier Type: -
Identifier Source: org_study_id