Metastatic Cancer
Conditions
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.
Interventions
BEHAVIORALMetastatic 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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTBilal A Siddiqui, MD
Outcome results
None listed