Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860961
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Prostate Adenocarcinoma Other: Questionnaire Administration Other: Survivorship Care Plan (SCP) Other: Treatment Plan Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Questionnaire Administration
Ancillary studies

Other: Survivorship Care Plan (SCP)
Given survivorship care plan

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.
Other: Questionnaire Administration
Ancillary studies

Other: Survivorship Care Plan (SCP)
Given survivorship care plan

Other: Treatment Plan
Given treatment plan




Primary Outcome Measures :
  1. Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their fasting blood glucose checked [ Time Frame: 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 for the treatment (Donner 1989) and tested with a 2-sided type I error of 0.05. A sensitivity analysis will be conducted assuming patients who have missing data at 24 months did not have their glucose checked or see their PCP or cardiologist.

  2. Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their cholesterol checked [ Time Frame: 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 for the treatment (Donner 1989) and tested with a 2-sided type I error of 0.05. A sensitivity analysis will be conducted assuming patients who have missing data at 24 months did not have their cholesterol checked or see their PCP or cardiologist.


Secondary Outcome Measures :
  1. Eligible screened patients with a PCP or cardiologist [ Time Frame: 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.

  2. High health literacy levels [ Time Frame: At baseline ]
    Will be associated with improved patient-reported coordination of care and satisfaction with care. Will be assessed using BHLS.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
  • Completion and submission of the Brief Health Literacy Screen, Coordination of Care, and Patient Satisfaction with Care within 42 days prior to registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860961


Locations
Show Show 74 study locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Ronald C Chen NRG Oncology
Layout table for additonal information
Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT03860961    
Other Study ID Numbers: NRG-CC007CD
NCI-2019-00794 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-CC007CD ( Other Identifier: NRG Oncology )
NRG-CC007CD ( Other Identifier: DCP )
NRG-CC007CD ( Other Identifier: CTEP )
UG1CA189867 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type