stop_circleTerminated/Withdrawn

Physician education

A Phase 4 study of regorafenib in metastatic colorectal cancer - Does educating physicians change patient outcomes?

Trial purpose

Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
23
Trial Dates
November 2014 - April 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gettysburg, 17325, United States
Completed
Skokie, 60077, United States
Completed
Lake City, 32024, United States
Terminated
Kingsport, 37660, United States
Terminated
Lafayette, 47905, United States
Terminated
Portsmouth, 23704, United States
Terminated
Canton, 44718, United States
Terminated
Fayetteville, 28304, United States
Terminated
Bristol, 24201, United States
Completed
Anaheim, 92801, United States
Terminated
Orange, 92668, United States
Completed
Skokie, 60076, United States
Completed
Houston, 77024, United States
Completed
Anniston, 36207, United States
Completed
Columbia, 21044, United States
Completed
Tulsa, 74146, United States
Completed
Tyler, 75701, United States

Primary Outcome

  • Proportion of patients who discontinue prior to documented progression of disease (PD) or death
    Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of treatment
    Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Dose intensity as percentage of planned dose
    Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information. Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of Grade 3 Hand-foot-skin reaction (HFSR), fatigue, diarrhea, hypertension
    Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken. Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Investigator comfort with the use of regorafenib and management of AEs as measured by questionnaire
    Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale. Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Satisfaction of investigator/nurse with enhanced drug-specific information via SMART questionnaire
    Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale. Due to insufficient sample size, the outcome measure was not calculated.
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

Does physician education influence side effect management and does it increase time on treatment in the absence of progression ? A phase 4 open-label trial with regorafenib in metastatic colorectal cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Supportive Care
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2