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Completed

NCT Number: NCT03860961

Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving 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.

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Key information

Conditions

Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kingman Regional Medical Center, Kingman, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survivorship Care Plan

Other

Given survivorship care plan

Treatment Plan

Other

Given treatment plan

Primary outcomes

  1. Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment

    Time frame: 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 outcomes

  1. Calculated Cardiovascular (CVD) Risk Score at Two Years

    Time frame: 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.

  2. 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)

    Time frame: 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.

  3. Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

    Time frame: 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 outcomes

  1. Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the Cancer Specialist

    Time frame: 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.

  2. Patient Satisfaction With Care With Respect to the Cancer Specialist

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NRG Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Mar 4, 2019
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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