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

Completed · Not applicable

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT03860961

Run by

NRG Oncology

People needed

550

Starts

2019-07-26

Expected to finish

2025-09-04

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• PRACTICE ELIGIBILITY CRITERIA
• 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 NRGCC007CD@nrgoncology.org).
• 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). Note: staff and physicians cannot be part of multiple practices
• For 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. As long as the clinicians (physicians, American Physician Partners [APPs]) are different for the patient populations of the two trials, a practice is eligible to participate in both trials
• 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

Where it is running

• Kaiser Permanente Dublin — Dublin, California, United States
• Kaiser Permanente Oakland-Broadway — Oakland, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Rohnert Park Cancer Center — Rohnert Park, California, United States
• The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• Kaiser Permanente Cancer Treatment Center — South San Francisco, California, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
• Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
• Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States
• Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho, United States
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
• Carle at The Riverfront — Danville, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Carle Physician Group-Effingham — Effingham, Illinois, United States
• Crossroads Cancer Center — Effingham, Illinois, United States
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
• Kingman Regional Medical Center — Kingman, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.