N/A
N=550
Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Prostate Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03860961 ↗Enrolled (actual)
550
Serious AEs
—
Results posted
Nov 2025
Primary outcome: Primary: Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment — 160; 157 Participants — p=0.9238
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Survivorship Care Plan (Other); Treatment Plan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- NRG Oncology
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment |
160; 157 | 0.9238 |
| SECONDARY Calculated Cardiovascular (CVD) Risk Score at Two Years |
0.257; 0.256 | 0.5609 |
| SECONDARY 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) |
5.29; 5.46 | — |
| SECONDARY Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP) |
81.96; 82.68 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 [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). 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
Data sourced from ClinicalTrials.gov (NCT03860961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.