Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

Investigators were supported with standard prescribing information.

Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off

Regorafenib (Stivarga, BAY73-4506)

iPAD application

The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.

Bayer specialist

Bayer Study Director

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.

A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?

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

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.

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.

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.

Bayer

SAF (N= 19) included all subjects who received at least one dose of the study medication.

Regorafenib (Stivarga, BAY 73-4506)

Participants received 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).

SMART

Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with standard prescribing information.

Standard of Care

Total

Age, Continuous

Sex: Female, Male

The study was terminated prematurely due to slow recruitment (23/300 subjects enrolled). No statistical analyses of efficacy parameters were performed.

Therapeutic Area Head

The study was pre-maturely terminated. No data were collected from participants for this assessment.

Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death

Duration of Treatment

Dose Intensity as Percentage of Planned Dose

Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension

Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire

Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.

Shared decision-making for PSA screening tool

Michael S Wilkes, MD PhD

Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve the interaction of physicians and their patients about prostate cancer screening. Educational material is provided in primary care practices using either standard paper information or a novel web-based interactive curriculum that explores the risks and benefits of screening measures for prostate cancer for older men. The impact of the intervention on shared decision-making with both actual and standardized patients will be assessed.

Prostate cancer is an important cause of death and disability in US men, but the value of screening for the disease with the prostate specific antigen (PSA) test remains highly controversial. Many primary care physicians use PSA testing routinely, with little patient counseling. Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. The intervention will be evaluated among 140 physicians within a variety of primary care settings (i.e., University-based clinics, staff-model managed care clinics, and military affiliated outpatient clinics). Approximately 10-15 actual patients of each participating physician will complete a post-visit questionnaire describing their discussion with their doctor about prostate cancer, PSA, and their decision about whether to be screened. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA. Study groups will be compared on the extent of shared decision-making they engage in with both actual and standardized patients. Pre- and post-study changes in physician knowledge and attitudes about PSA as well as the physicians' pre- and post-study PSA test ordering rates will be ascertained.

Shared Decision Making: Prostate Cancer Screening

Centers for Disease Control and Prevention

Julie Rainwater, PhD

Clinic-focused intervention: The clinicians and clinical staff in each of the clinics will be scheduled for training sessions. The provider trainings will be designed for clinicians and clinical staff and will be conducted in at least two separate sessions of approximately 3 hours total duration. The sessions will be scheduled to accommodate the clinic schedule, but will be held with no more than 1 month between them. Participants in clinic training sessions will receive continuing education credit.

Clinic-focused and patient focused intervention: The clinic focused-intervention as described in Arm 2 will be combined with a patient-focused intervention.

Patient focused intervention: CRC education packets, based upon previously developed CDC CRC patient education materials, have been adapted for each study site. These CRC educational packets will be mailed to average-risk patients aged 50-80 years who are due for CRC screening (based on electronic records) and who schedule a non-acute ambulatory care visit in clinics assigned to the patient-focused intervention. A cover letter signed by the patient's physician will be included with each packet. The packets will be mailed approximately 1 week before the medical appointment.

No intervention will be conducted in this arm of the study.

Usual care

The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff. The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based. The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.

Clinic-focused intervention

This arm will combine the clinic-focused intervention and the patient-focused intervention. The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.

Clinic- and patient-focused

Judith Lee Smith, PhD

This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics. The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting. The intervention will be implemented within primary care clinics in two managed care organizations (MCOs). The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer
Shared Decision Making: Prostate Cancer Screening	NCT00207649	Prostate Cancer	Shared decision...	-	Centers for Disease Control and Prevention
Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics	NCT00737646	Colorectal Canc...	Usual care Clinic-focused ... Clinic- and pat...	50 Years - 75 Years	Centers for Disease Control and Prevention
Shared Decision Making: Prostate Cancer Screening	NCT00207649	Prostate Cancer	Shared decision...	-	Centers for Disease Control and Prevention

Spots Global Cancer Trial Database for physician education