Clinical trial NCT03148093: The CHOICE Registry
Official title: The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Registry
Patient Reported Outcomes
Treatment Patterns
Prescription Use
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from community and academic medical centers in the United States.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)
timeFrame: Approximately 15 months
measure: Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)
timeFrame: Approximately 15 months
measure: Duration of therapy
timeFrame: Approximately 15 months
measure: Reasons for dose adjustments and/or discontinuation of treatments
timeFrame: Approximately 15 months
Secondary outcomes:
measure: Healthcare Resource Utilization
timeFrame: Approximately 15 months
measure: Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
timeFrame: Approximately 15 months
measure: 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)
timeFrame: Approximately 15 months
measure: Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L
timeFrame: Approximately 15 months
measure: Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)
timeFrame: Approximately 15 months
measure: Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)
timeFrame: Approximately 15 months
Other outcomes:
measure: Overall Survival
timeFrame: Approximately 15 months
measure: Progression free survival
timeFrame: Approximately 15 months
Locations:
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
Study officials:
References: