The CHOICE Registry

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.

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from community and academic medical centers in the United States.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Reasons for dose adjustments and/or discontinuation of treatments	Approximately 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Resource Utilization	To characterize (physician visits, pharmacotherapy, hospitalizations, etc.) in patients receiving various treatment regimens	Approximately 15 months
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
Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)		Approximately 15 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival is defined as the time from the date of randomization to the date of death	Approximately 15 months
Progression free survival	Progression free survival is defined as the time from the date of randomization until radiological disease	Approximately 15 months

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): October 20, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Registry; Metastatic Colorectal Cancer; Patient Reported Outcomes; Treatment Patterns; Prescription Use
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MA-102-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No