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

NCT03860961 | Completed Results DMC

• 3 other identifiers: NRG-CC007CDNCI-2019-00794UG1CA189867
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 79

Brief 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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment

  A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria: * saw a primary care provider (PCP) or cardiologist * had fasting blood glucose checked * had fasting cholesterol check.

  During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.

Secondary Outcomes (3)

• Calculated Cardiovascular (CVD) Risk Score at Two Years

  Two years after completion of approximately 4-9 weeks of radiation therapy.

• Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

  Two years after completion of approximately 4-9 weeks of radiation therapy.

• Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

  Two years after completion of approximately 4-9 weeks of radiation therapy.

Other Outcomes (2)

• Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the Cancer Specialist

  Two years after completion of approximately 4-9 weeks of radiation therapy.

• Patient Satisfaction With Care With Respect to the Cancer Specialist

  Two years after completion of approximately 4-9 weeks of radiation therapy.

Study Arms (2)

Arm A (Survivorship Care Plan)

ACTIVE COMPARATOR

Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).

Other: Survivorship Care Plan

Arm B (Enhanced Survivorship Care Plan)

EXPERIMENTAL

Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.

Other: Survivorship Care Plan; Other: Treatment Plan

Interventions

Survivorship Care Plan OTHER

Given survivorship care plan

Arm A (Survivorship Care Plan); Arm B (Enhanced Survivorship Care Plan)

Treatment Plan OTHER

Given treatment plan

Arm B (Enhanced Survivorship Care Plan)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• NRG Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (79)

Kingman Regional Medical Center

Kingman, Arizona, 86401, United States

Location

Kaiser Permanente Dublin

Dublin, California, 94568, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

Location

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

Location

University of Kansas Cancer Center-West

Kansas City, Kansas, 66112, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States

Location

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

Location

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

Location

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703, United States

Location

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

Location

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

Location

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

Location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, 28462, United States

Location

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Saint Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, 54915, United States

Location

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, 53045, United States

Location

Ascension Mercy Hospital

Oshkosh, Wisconsin, 54904, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

(215) 574-3208

Study Officials

• Ronald C Chen

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 4, 2019
• Study Start: July 26, 2019
• Primary Completion: November 14, 2024
• Study Completion: September 4, 2025
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-09

Locations

US (79)