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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
23
Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Orange, California, United States
Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death
Time frame: Up to 1 year
Duration of Treatment
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Lake City, Florida, United States
Unnamed facility
Skokie, Illinois, United States
Unnamed facility
Skokie, Illinois, United States
Unnamed facility
Lafayette, Indiana, United States
Unnamed facility
Columbia, Maryland, United States
Unnamed facility
Fayetteville, North Carolina, United States
Unnamed facility
Canton, Ohio, United States
...and 7 more locations