Prostate Adenocarcinoma
Conditions
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. Practices are randomized to 1 of 2 arms. After completion of study, patients are followed up periodically.
Interventions
Given survivorship care plan
OTHERTreatment Plan
Given treatment plan
Sponsors
National Cancer Institute (NCI)
NRG Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 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) * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment | During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Cardiovascular (CVD) Risk Score at Two Years | Two years after completion of approximately 4-9 weeks of radiation therapy. | 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. |
| 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. | 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. |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Patient Satisfaction With Care With Respect to the Cancer Specialist | Two years after completion of approximately 4-9 weeks of radiation therapy. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 833 participants screened at randomized practices, 550 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (SCP) Practices review a SCP with patients and send it to the PCP during the last week of RT. | 277 |
| Arm B (Enhanced SCP) 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. | 273 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 6 |
| Overall Study | Incomplete two-year data | 4 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 11 |
Baseline characteristics
| Characteristic | Arm A (SCP) | Arm B (Enhanced SCP) | Total |
|---|---|---|---|
| Age, Continuous | 70 years | 70 years | 70 years |
| Age, Customized < 65 years | 70 Participants | 61 Participants | 131 Participants |
| Age, Customized ≥ 65 years | 207 Participants | 212 Participants | 419 Participants |
| Current smoker | 31 Participants | 33 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 268 Participants | 261 Participants | 529 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 12 Participants |
| Has Diabetes | 70 Participants | 72 Participants | 142 Participants |
| Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Adequate | 201 Participants | 175 Participants | 376 Participants |
| Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Inadequate | 30 Participants | 35 Participants | 65 Participants |
| Health Literacy Level determined by Brief Health Literacy Screen (BHLS) Marginal | 45 Participants | 61 Participants | 106 Participants |
| Number of comorbidities determined by the Adult Comorbitity Evaluation-27 (ACE-27) ≤ 2 | 185 Participants | 181 Participants | 366 Participants |
| Number of comorbidities determined by the Adult Comorbitity Evaluation-27 (ACE-27) >2 | 92 Participants | 92 Participants | 184 Participants |
| Past smoker | 142 Participants | 139 Participants | 281 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 42 Participants | 81 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) White | 229 Participants | 220 Participants | 449 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 277 Participants | 273 Participants | 550 Participants |
| Uses hypertension medication | 187 Participants | 179 Participants | 366 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.
Population: Eligible participants from randomized practices with necessary data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Survivorship Care Plan) | Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment | 160 Participants |
| Arm B (Enhanced Survivorship Care Plan) | Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment | 157 Participants |
Comparison: Cluster-randomized trial, cluster=practice, maximum 25 patients/practice. Assuming 14 pts/practice, cluster size coefficient of variation of 0.5, intra-cluster correlation (ρ) of 0.04, design effect 1.51, and 59.8% of Arm A patients meeting the criteria provides 80% power for a two-sided α=0.05 two-sample test of proportions to detect a 15% absolute improvement in percentage of patients meeting the criteria with 544 patients (after adjusted for withdrawal and loss to follow-up).p-value: 0.9238Chi-squared, Corrected
Secondary
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.
Time frame: Two years after completion of approximately 4-9 weeks of radiation therapy.
Population: Eligible participants with CVD risk score at two years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Survivorship Care Plan) | Calculated Cardiovascular (CVD) Risk Score at Two Years | 0.257 score on a scale | Standard Deviation 0.134 |
| Arm B (Enhanced Survivorship Care Plan) | Calculated Cardiovascular (CVD) Risk Score at Two Years | 0.256 score on a scale | Standard Deviation 0.135 |
p-value: 0.5609Mixed Models Analysis
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)
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.
Time frame: Two years after completion of approximately 4-9 weeks of radiation therapy.
Population: Eligible participants with two-year CPCI data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Survivorship Care Plan) | 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 score on a scale | Standard Deviation 0.96 |
| Arm B (Enhanced Survivorship Care Plan) | 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) | 5.46 score on a scale | Standard Deviation 0.97 |
Secondary
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.
Time frame: Two years after completion of approximately 4-9 weeks of radiation therapy.
Population: Eligible participants with two-year Patient Satisfaction with Care questionnaire data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Survivorship Care Plan) | Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP) | 81.96 score on a scale | Standard Deviation 9.18 |
| Arm B (Enhanced Survivorship Care Plan) | Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP) | 82.68 score on a scale | Standard Deviation 11.8 |
Other Pre-specified
Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the Cancer Specialist
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.
Time frame: Two years after completion of approximately 4-9 weeks of radiation therapy.
Other Pre-specified
Patient Satisfaction With Care With Respect to the Cancer Specialist
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.
Time frame: Two years after completion of approximately 4-9 weeks of radiation therapy.