Program for early detection and management of side effects in metastatic cancer patients
A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
This study tests a smartphone program that helps people with metastatic cancer spot and manage side effects from their treatment early on to see if it reduces the chances of stopping therapy due to these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06693687 on ClinicalTrials.gov |
What this trial studies
This study evaluates the ApricityCare program aimed at identifying early clinical signs of treatment-related adverse events in patients with metastatic cancer. The primary objective is to determine the rate of therapy discontinuation due to toxicity among participants using the program. Secondary objectives include measuring participant engagement with the program, frequency of symptom reporting, and response times to reported symptoms. The study focuses on patients receiving systemic anti-cancer therapy and utilizes a smartphone application for monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of metastatic cancer who are planning to receive systemic anti-cancer therapy.
Not a fit: Patients with medical, psychological, or social conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could help reduce treatment discontinuation and improve management of side effects in metastatic cancer patients.
How similar studies have performed: Other studies have shown promise in using technology for monitoring and managing treatment-related side effects, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Bilal A Siddiqui, MD
- Email: basiddiqui@mdanderson.org
- Phone: (713) 563-4600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.