Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Purpose
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
- Cancer Survivor
- Prostate Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
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).
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard Survivorship Care Plan (SCP) |
Practices review a SCP with patients and send it to the PCP during the last week of RT. |
|
|
Experimental Enhanced Survivorship Care Plan (SCP) |
Practices review a treatment plan with patient and send it to the PCP at the beginning of RT. Practices also review a SCP with patients and send it to the PCP during the last week of RT. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- NRG Oncology
Study Contact
Detailed 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.