Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic Colorectal Cancer, Registry, Patient Reported Outcomes, Treatment Patterns, Prescription Use
Brief summary
The CHOICE Registry will describe real-world treatment patterns and physician and patient (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd line metastatic colorectal cancer.
Detailed description
A prospective, non-interventional, observational, approach will be employed. All patient follow-up visits and other interactions will be established by the physician investigator: the CHOICE Registry will not impose a fixed schedule of follow-up visits. Data will be obtained in conjunction with actual follow-up visits to support treatment and various assessments of disease progression, patient quality of life and caregiver burden, and resource utilization. Patients will be followed for minimum of 15 months. All prescribed and administered medications, treatment adjustments and duration will be documented by the physician investigator treating the patient as per standard of care. The CHOICE Registry will not impose any change to the treatment regimen prescribed by physicians participating in the Registry. Adult males and females with metastatic colorectal cancer (having received first and second line treatment, and upon initiation of third line or later treatment) will be eligible to participate. Approximately 1000 patients will be enrolled by approximately 30 to 40 physician investigators representing both community and academic medical centers in the United States. Descriptive statistics will be employed to address the key research objectives of the CHOICE Registry, such as a description of patients receiving various second (and/or subsequent) lines of treatment in the management of metastatic colorectal cancer in real world clinical settings, and the associated clinical, economic, and humanistic (patient-reported) outcomes.
Interventions
None listed
Sponsors
Taiho Oncology, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Diagnosis of metastatic CRC 3. Having completed first and second lines of treatment for metastatic CRC 4. Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment 5. Ability to understand and read English or Spanish 6. Willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf
Exclusion criteria
1. Patient is unwilling or unable to participate in the Registry at the time of enrollment 2. The patient is currently participating in an investigational clinical trial 3. Patients not having mental capacity and or ability to participate in the Registry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reasons for dose adjustments and/or discontinuation of treatments | Approximately 15 months |
| Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19) | Approximately 15 months |
| Real-world treatment patterns as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Approximately 15 months |
| Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L | Approximately 15 months |
| Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ) | Approximately 15 months |
| Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI) | Approximately 15 months |
| Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI) | Approximately 15 months |
| Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.) | Approximately 15 months |
| Duration of therapy | Approximately 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI) | Approximately 15 months | — |
| Healthcare Resource Utilization | Approximately 15 months | To characterize (physician visits, pharmacotherapy, hospitalizations, etc.) in patients receiving various treatment regimens |
| Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19) | Approximately 15 months | — |
| Quality-of-life of patients receiving specific treatment regimens for mCRC per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Approximately 15 months | — |
| Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L | Approximately 15 months | — |
| Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ) | Approximately 15 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Approximately 15 months | Overall survival is defined as the time from the date of randomization to the date of death |
| Progression free survival | Approximately 15 months | Progression free survival is defined as the time from the date of randomization until radiological disease |
Countries
United States
Outcome results
None listed