The CHOICE Registry

Metastatic Colorectal Cancer Clinical Trial

Official title:

The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03148093
• Other study ID #: MA-102-01
• Status: Terminated
• Phase: N/A
• First received: April 4, 2017
• Last updated: January 26, 2018
• Start date: June 30, 2017
• Est. completion date: December 13, 2017

Study information

• Verified date: January 2018
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 13, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
United States	Ingalls Memorial Hospital	Harvey	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	Overall survival is defined as the time from the date of randomization to the date of death	Approximately 15 months
Other	Progression free survival	Progression free survival is defined as the time from the date of randomization until radiological disease	Approximately 15 months
Primary	Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)		Approximately 15 months
Primary	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
Primary	Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L		Approximately 15 months
Primary	Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)		Approximately 15 months
Primary	Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)		Approximately 15 months
Primary	Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)		Approximately 15 months
Primary	Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)		Approximately 15 months
Primary	Duration of therapy		Approximately 15 months
Primary	Reasons for dose adjustments and/or discontinuation of treatments		Approximately 15 months
Secondary	Healthcare Resource Utilization	To characterize (physician visits, pharmacotherapy, hospitalizations, etc.) in patients receiving various treatment regimens	Approximately 15 months
Secondary	Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)		Approximately 15 months
Secondary	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
Secondary	Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L		Approximately 15 months
Secondary	Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)		Approximately 15 months
Secondary	Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)		Approximately 15 months