Prostate Cancer Clinical Trial

Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Summary

This trial studies how well increasing the dose of survivorship care planning improves care and outcomes in prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. There is a need for coordinated care between the cancer care team with the primary care team. This is especially important for prostate cancer survivors who need routine cancer care follow-up with their radiation oncologist and also coordinated routine follow-up with their primary care provider (PCP). This is important because androgen deprivation therapy increases a patient's risk for developing diabetes, hypercholesterolemia, and cardiovascular events. Increasing the dose of survivorship may improve care and outcomes of cancer survivors than standard practices.

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Full Description

PRIMARY OBJECTIVES:

I. To determine if the experimental arm (increased doses of survivorship care planning [SCP]) has more patients who saw a primary care provider and had blood glucose and cholesterol checked in year 2 (13-24 months) after finishing radiation therapy (RT) as compared to the control arm.

SECONDARY OBJECTIVES:

I. To determine if patients who receive increased doses of SCP have lower cardiovascular disease (CVD) risk score at 2 years as compared to patients who receive a one-time SCP.

II. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their primary care provider (PCP) or cardiologist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their PCP or cardiologist.

III. To determine the number of patients eligible, but without a PCP/cardiologist.

IV. To describe the current practice related to SCP delivery and prostate cancer survivor monitoring in participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practices.

EXPLORATORY OBJECTIVES:

I. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their cancer specialist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their cancer specialist.

OUTLINE: Practices are randomized to 1 of 2 arms.

ARM A (STANDARD): Practices review a SCP with patients and send it to the PCP during the last week of RT.

ARM B (ENHANCED SCP): Practices review a treatment plan with patient and send it to the PCP at the beginning of RT. Practices also review a SCP as arm A.

After completion of study, patients are followed up periodically.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

PRACTICE ELIGIBILITY CRITERIA

Practices (defined as a single NCORP component or subcomponent; or NCORP component and/or subcomponents that share the same physicians and/or staff, but are in different locations) will be randomized to receive standard of care (control arm) or increased SCP dose (experimental arm) once all of the eligibility criteria specified below have been met.
All institutions participating in a practice are NCORP components or sub-components
Have a mechanism for delivering SCPs to prostate cancer patients. Practices that currently provide SCPs are eligible but for this trial will need to use the study-provided SCP template.
See at least 10 patients meeting eligibility criteria per year.
Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website) by each practice to [email protected]).
Institutional Review Board (IRB) approval
Each principal investigator (PI) and research assistant (RA) at a NCORP practice must complete NRG-CC007CD SCP training. A training certificate will need to be completed and uploaded to the CTSU Regulatory Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the CTSU website).
Any site participating within a practice that is participating on Wake Forest study, WF-1804CD is not able to participate in this trial in order to not impact the fidelity of either trial.

PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)

The participant must be able to complete required questionnaires in English

The participant must have a diagnosis of prostate adenocarcinoma that will be treated with RT plus androgen deprivation therapy (ADT) with curative intent. Both definitive RT (intact prostate) and postprostatectomy RT patients are eligible

The ADT must be planned for at least 4 months and must include luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist
ADT may have started for no more than 120 days before registration
The participant must have a primary care provider and/or cardiologist or plan to obtain one
Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Study is for people with:

Prostate Cancer

Estimated Enrollment:

834

Study ID:

NCT03860961

Recruitment Status:

Active, not recruiting

Sponsor:

NRG Oncology

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There are 73 Locations for this study

See Locations Near You

Kingman Regional Medical Center
Kingman Arizona, 86401, United States
Kaiser Permanente Dublin
Dublin California, 94568, United States
Kaiser Permanente Oakland-Broadway
Oakland California, 94611, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park California, 94928, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville California, 95678, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California, 95051, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco California, 94080, United States
Helen F Graham Cancer Center
Newark Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Augusta University Medical Center
Augusta Georgia, 30912, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa Idaho, 83686, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls Idaho, 83301, United States
John H Stroger Jr Hospital of Cook County
Chicago Illinois, 60612, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Luke's Hospital
Cedar Rapids Iowa, 52402, United States
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
University of Kansas Cancer Center-West
Kansas City Kansas, 66112, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park Kansas, 66210, United States
University of Kansas Health System Saint Francis Campus
Topeka Kansas, 66606, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
MaineHealth Coastal Cancer Treatment Center
Bath Maine, 04530, United States
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States
MaineHealth Cancer Care Center of York County
Sanford Maine, 04073, United States
Maine Medical Center- Scarborough Campus
Scarborough Maine, 04074, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
University of Kansas Cancer Center - North
Kansas City Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City Missouri, 64116, United States
Delbert Day Cancer Institute at PCRMC
Rolla Missouri, 65401, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Carson Tahoe Regional Medical Center
Carson City Nevada, 89703, United States
OptumCare Cancer Care at Seven Hills
Henderson Nevada, 89052, United States
OptumCare Cancer Care at Charleston
Las Vegas Nevada, 89102, United States
OptumCare Cancer Care at MountainView
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas Nevada, 89169, United States
Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
CaroMont Regional Medical Center
Gastonia North Carolina, 28054, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
NHRMC Radiation Oncology - Supply
Supply North Carolina, 28462, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington North Carolina, 28401, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington North Carolina, 28401, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Saint Rita's Medical Center
Lima Ohio, 45801, United States
Christiana Care Health System-Concord Health Center
Chadds Ford Pennsylvania, 19317, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
Ascension Saint Elizabeth Hospital
Appleton Wisconsin, 54915, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield Wisconsin, 53045, United States
Ascension Mercy Hospital
Oshkosh Wisconsin, 54904, United States
Aspirus Regional Cancer Center
Wausau Wisconsin, 54401, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

834

Study ID:

NCT03860961

Recruitment Status:

Active, not recruiting

Sponsor:


NRG Oncology

How clear is this clinincal trial information?

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