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.
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.
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
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There are 73 Locations for this study
Kingman Arizona, 86401, United States
Dublin California, 94568, United States
Oakland California, 94611, United States
Rancho Cordova California, 95670, United States
Rohnert Park California, 94928, United States
Roseville California, 95678, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Rehoboth Beach Delaware, 19971, United States
Washington District of Columbia, 20007, United States
Augusta Georgia, 30912, United States
Boise Idaho, 83712, United States
Fruitland Idaho, 83619, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83686, United States
Twin Falls Idaho, 83301, United States
Chicago Illinois, 60612, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Mattoon Illinois, 61938, United States
Mount Vernon Illinois, 62864, United States
Urbana Illinois, 61801, United States
Cedar Rapids Iowa, 52402, United States
Fairway Kansas, 66205, United States
Kansas City Kansas, 66112, United States
Kansas City Kansas, 66160, United States
Overland Park Kansas, 66210, United States
Topeka Kansas, 66606, United States
Westwood Kansas, 66205, United States
Bath Maine, 04530, United States
Portland Maine, 04102, United States
Sanford Maine, 04073, United States
Scarborough Maine, 04074, United States
Grand Rapids Michigan, 49503, United States
Maplewood Minnesota, 55109, United States
Kansas City Missouri, 64154, United States
Lee's Summit Missouri, 64064, United States
North Kansas City Missouri, 64116, United States
Rolla Missouri, 65401, United States
Springfield Missouri, 65807, United States
Carson City Nevada, 89703, United States
Henderson Nevada, 89052, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
Flemington New Jersey, 08822, United States
Morristown New Jersey, 07960, United States
Albuquerque New Mexico, 87102, United States
Gastonia North Carolina, 28054, United States
Pinehurst North Carolina, 28374, United States
Supply North Carolina, 28462, United States
Wilmington North Carolina, 28401, United States
Wilmington North Carolina, 28401, United States
Chillicothe Ohio, 45601, United States
Lima Ohio, 45801, United States
Chadds Ford Pennsylvania, 19317, United States
Danville Pennsylvania, 17822, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Greer South Carolina, 29651, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29303, United States
Appleton Wisconsin, 54915, United States
Brookfield Wisconsin, 53045, United States
Oshkosh Wisconsin, 54904, United States
Wausau Wisconsin, 54401, United States
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