The CHOICE Registry
Status: | Terminated |
---|---|
Conditions: | Colorectal Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2018 |
Start Date: | June 30, 2017 |
End Date: | December 13, 2017 |
The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer
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.
(and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd
line metastatic colorectal cancer.
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.
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.
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
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