Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
- Conditions
- Prostate Adenocarcinoma
- Registration Number
- NCT03860961
- Lead Sponsor
- NRG Oncology
- 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.
- Detailed Description
PRIMARY OBJECTIVE:
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 OBJECTIVE:
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 546
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PRACTICE ELIGIBILITY CRITERIA
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All institutions participating in a practice are NCORP components or sub-components
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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.
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See at least 10 patients meeting eligibility criteria per year.
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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).
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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
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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
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PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)
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The participant must be able to complete required questionnaires in English
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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
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The participant must have a primary care provider and/or cardiologist or plan to obtain one
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Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)
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The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients who saw a primary care provider (PCP) or cardiologist and had fasting blood glucose and cholesterol checked At 24 months after completion of radiation therapy (RT) Will be evaluated on the individual level using an adjusted chi-square test that computes clustering correction factors computed separately in each treatment (Donner 1989) and tested with a 2-sided type I error of 0.05. A generalized estimating equation (GEE) (Liang 1986), adjusting for practice as a random covariate as part of a 2 level hierarchy (patients nested within clusters) will be used to determine the effect of intervention, androgen deprivation therapy (ADT) duration, person delivering the survivorship care plan (SCP), whether the patient saw a PCP or cardiologist, and possible confounders such as age, race, and number of baseline cardiovascular disease risk factors (none, hypertension, diabetes, hypercholesterolemia, and/or known coronary heart disease). A sensitivity analysis will be conducted assuming patients who have missing data at 24 months did not have their glucose and cholesterol checked or see their PCP or cardiologist.
- Secondary Outcome Measures
Name Time Method Current practice related to SCP delivery and prostate cancer survivor monitoring Prior to randomization Descriptive statistics, such as frequencies for the number of sites that currently use a treatment plan and/or SCP, and routinely perform testing and means for the percent of patients and/or their PCPs who receive a treatment plan and/or SCP, will be performed. Comparisons by arm will be made using a chi square test or t-test. If significant differences exist, at a two-sided significance level of 0.05, the respective covariates may be added to the models for the primary and secondary endpoints.
Calculated cardiovascular (CVD) risk score At baseline and 24 months Will be calculated using the American Heart Association Risk Calculator. A linear mixed model (Laird 1982) with practice as a random covariate as part of a 2 level hierarchy (patients nested within clusters) will be used to compare the treatment arms using a significance level of 0.05.
Coordination of care with respect to the PCP or cardiologist At baseline and up to 24 months after completion of RT Will be measured using the components of Primary Care Index. Distribution will be provided for the entire study cohort only and not by arm. Statistical testing using a t-test (Wilcoxon test if the data is not normal) will only be performed if there is sufficient data on the control arm to allow for between treatment arm differences. A linear mixed effects model with practice as a random covariate as part of a 3 level hierarchy (surveys nested within patients nested within clusters) will be used to assess the effect of the intervention on the coordination of care for the PCP or cardiologist, with baseline score as a covariate, at 12 months and 24 months after completing RT (Liang 1986). Similar models will be used to determine the effect of various baseline covariates, including ADT duration, number of cardiovascular risk factors, person delivering the SCP, Brief Health Literacy Screen (BHLS) score, and race ethnicity on the coordination of care scores.
Satisfaction with care with respect to the PCP or cardiologist At baseline and up to 24 months after completion of RT Will be measured using the Patient Satisfaction with Care questionnaire. Distribution will be provided for the entire study cohort only and not by arm. Statistical testing using a t-test (Wilcoxon test if the data is not normal) will only be performed if there is sufficient data on the control arm to allow for between treatment arm differences. A linear mixed effects model with practice as a random covariate as part of a 3 level hierarchy (surveys nested within patients nested within clusters) will be used to assess the effect of the intervention on the satisfaction with cancer care for the PCP or cardiologist, with baseline score as a covariate, at 12 months and 24 months after completing RT (Liang 1986). Similar models will be used to determine the effect of various baseline covariates, including ADT duration, number of cardiovascular risk factors, person delivering the SCP, BHLS score, and race ethnicity on the satisfaction with cancer care scores.
Eligible screened patients with a PCP or cardiologist At baseline Each National Cancer Institute NCI Community Oncology Research Program (NCORP) practice will screen (step 0) and keep a log of all patients who are eligible, regardless of whether the patient has an existing PCP and/or cardiologist. The percentage of the enrolled patients out of all eligible patients (excluding the PCP requirement) will be provided along with the percentages broken down by practice.
High health literacy levels At baseline Will be associated with improved patient-reported coordination of care and satisfaction with care. Will be assessed using BHLS.
Trial Locations
- Locations (79)
SSM Health Good Samaritan
🇺🇸Mount Vernon, Illinois, United States
Kingman Regional Medical Center
🇺🇸Kingman, Arizona, United States
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
Scroll for more (69 remaining)SSM Health Good Samaritan🇺🇸Mount Vernon, Illinois, United States