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Recruiting

NCT Number: NCT06693687

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Bilal A Siddiqui, MD

CONTACT

[email protected]

713-563-4600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Metastatic Cancer

Behavioral

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.

Primary outcomes

  1. Safety and Adverse Events

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bilal A Siddiqui, MD

CONTACT

[email protected]

(713) 563-4600

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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