A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metastatic Cancer.
- Who it may be relevant to
- Registry conditions: Metastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Safety and Adverse Events [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06693687 · 2024-0229 · NCI-2024-09566