A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer

Not Applicable

Recruiting

• Conditions: Metastatic Cancer

• Registration Number: NCT06693687
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

Primary Objective • To determine the rate of therapy discontinuation due to toxicity among patients using ApricityCare.

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.

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Study Start: 2024-12-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

• Age 18 years of age or older

• 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

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events	Through 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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States