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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03860961
• Other study ID #: NRG-CC007CD
• Secondary ID: NCI-2019-00794NR
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: November 30, 2029

Study information

• Verified date: January 2024
• Source: NRG Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 834
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer Survivor
• Prostate Adenocarcinoma

Intervention

Other:
• Questionnaire Administration
Ancillary studies
• Survivorship Care Plan (SCP)
Given survivorship care plan
• Treatment Plan
Given treatment plan

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Ascension Saint Elizabeth Hospital	Appleton	Wisconsin
United States	Augusta University Medical Center	Augusta	Georgia
United States	MaineHealth Coastal Cancer Treatment Center	Bath	Maine
United States	Saint Luke's Cancer Institute - Boise	Boise	Idaho
United States	Ascension Southeast Wisconsin Hospital - Elmbrook Campus	Brookfield	Wisconsin
United States	Carson Tahoe Regional Medical Center	Carson City	Nevada
United States	Saint Luke's Hospital	Cedar Rapids	Iowa
United States	Christiana Care Health System-Concord Health Center	Chadds Ford	Pennsylvania
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Carle at The Riverfront	Danville	Illinois
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Kaiser Permanente Dublin	Dublin	California
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Crossroads Cancer Center	Effingham	Illinois
United States	University of Kansas Clinical Research Center	Fairway	Kansas
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Saint Luke's Cancer Institute - Fruitland	Fruitland	Idaho
United States	CaroMont Regional Medical Center	Gastonia	North Carolina
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Saint Francis Cancer Center	Greenville	South Carolina
United States	Saint Francis Hospital	Greenville	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	OptumCare Cancer Care at Seven Hills	Henderson	Nevada
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	University of Kansas Cancer Center - North	Kansas City	Missouri
United States	University of Kansas Cancer Center-West	Kansas City	Kansas
United States	Kingman Regional Medical Center	Kingman	Arizona
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada - Central Valley	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada - Town Center	Las Vegas	Nevada
United States	OptumCare Cancer Care at Charleston	Las Vegas	Nevada
United States	OptumCare Cancer Care at Fort Apache	Las Vegas	Nevada
United States	OptumCare Cancer Care at MountainView	Las Vegas	Nevada
United States	University of Kansas Cancer Center - Lee's Summit	Lee's Summit	Missouri
United States	Saint Rita's Medical Center	Lima	Ohio
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Saint Luke's Cancer Institute - Meridian	Meridian	Idaho
United States	Morristown Medical Center	Morristown	New Jersey
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Saint Luke's Cancer Institute - Nampa	Nampa	Idaho
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	Helen F Graham Cancer Center	Newark	Delaware
United States	University of Kansas Cancer Center at North Kansas City Hospital	North Kansas City	Missouri
United States	Kaiser Permanente Oakland-Broadway	Oakland	California
United States	Ascension Mercy Hospital	Oshkosh	Wisconsin
United States	University of Kansas Cancer Center-Overland Park	Overland Park	Kansas
United States	FirstHealth of the Carolinas-Moore Regional Hospital	Pinehurst	North Carolina
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Kaiser Permanente-Rancho Cordova Cancer Center	Rancho Cordova	California
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Rohnert Park Cancer Center	Rohnert Park	California
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	The Permanente Medical Group-Roseville Radiation Oncology	Roseville	California
United States	MaineHealth Cancer Care Center of York County	Sanford	Maine
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Maine Medical Center- Scarborough Campus	Scarborough	Maine
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	Kaiser Permanente Cancer Treatment Center	South San Francisco	California
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Novant Cancer Institute Radiation Oncology - Supply	Supply	North Carolina
United States	University of Kansas Health System Saint Francis Campus	Topeka	Kansas
United States	Saint Luke's Cancer Institute - Twin Falls	Twin Falls	Idaho
United States	Carle Cancer Center	Urbana	Illinois
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas
United States	Novant Health Cancer Institute Radiation Oncology - Wilmington	Wilmington	North Carolina
United States	Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
NRG Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their fasting blood glucose checked	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.	At 24 months after completion of radiation therapy (RT)
Primary	Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their cholesterol checked	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.	At 24 months after completion of radiation therapy (RT)
Secondary	Eligible screened patients with a PCP or cardiologist	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.	At baseline
Secondary	High health literacy levels	Will be associated with improved patient-reported coordination of care and satisfaction with care. Will be assessed using BHLS.	At baseline