NCT03148093

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

April 4, 2017

Last Update Submit

August 30, 2024

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal CancerRegistryPatient Reported OutcomesTreatment PatternsPrescription Use

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (6)

  • Healthcare Resource Utilization

    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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Overall Survival

    Approximately 15 months

  • Progression free survival

    Approximately 15 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18
  • Diagnosis of metastatic CRC
  • Having completed first and second lines of treatment for metastatic CRC
  • Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment
  • Ability to understand and read English or Spanish
  • 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

You may not qualify if:

  • Patient is unwilling or unable to participate in the Registry at the time of enrollment
  • The patient is currently participating in an investigational clinical trial
  • Patients not having mental capacity and or ability to participate in the Registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

May 10, 2017

Study Start

June 30, 2017

Primary Completion

October 20, 2017

Study Completion

December 13, 2017

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations

US(1)