Prostate AdenocarcinomaNCT03860961
Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
A study testing Survivorship Care Plan and Treatment Plan in people with Prostate Adenocarcinoma, run by NRG Oncology at 79 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Survivorship Care Plan and Treatment Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 79 sitesUnited States
- Study dates
- 26 Jul 2019to 4 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
Augusta University Medical Center
Augusta, Georgia, 30912
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Carle at The Riverfront
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Kaiser Permanente Dublin
Dublin, California, 94568
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Hunterdon Medical Center
Flemington, New Jersey, 08822
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
University of Kansas Cancer Center-West
Kansas City, Kansas, 66112
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Kingman Regional Medical Center
Kingman, Arizona, 86401
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Saint Rita's Medical Center
Lima, Ohio, 45801
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Morristown Medical Center
Morristown, New Jersey, 07960
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Helen F Graham Cancer Center
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
CoxHealth South Hospital
Springfield, Missouri, 65807
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, 28462
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Carle Cancer Center
Urbana, Illinois, 61801
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
Official title: Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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 OBJECTIVE:
- 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.
Practices are randomized to 1 of 2 arms. After completion of study, patients are followed up periodically.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Survivorship Care Plan, Treatment Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care PlanOther
Given survivorship care plan
Treatment PlanOther
Given treatment plan
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Survivorship Care Plan; Other: Treatment Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
CVD risk score is obtained using the American Heart Association Risk Calculator (Goff et al, 2013). The calculator requires sex (all participants are male in this trial), age, race (White, African American, Other), HDL, total cholesterol, systolic blood pressure, diabetes (yes/no), treatment for hypertension (yes/no), smoker (yes/no), and provides a 10-year risk of atherosclerotic cardiovascular disease (ASCVD) events ranging from 0 (low risk) to 1 (high risk). The calculator documentation states that risk may be overestimated or underestimated for some subgroups of the race category "Other", therefore score is not calculated for any participants in this category.
Measured: 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)
The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score.
Measured: 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)
This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.
Measured: Two years after completion of approximately 4-9 weeks of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start26 Jul 2019
- Primary completion14 Nov 2024
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronald C Chen, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860961
- Sponsor's protocol ID
- NRG-CC007CD
- Other IDs
- NCI-2019-00794, NRG-CC007CD, NRG-CC007CD, NRG-CC007CD, UG1CA189867
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2019
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.