Status:
COMPLETED
A Survivorship Care Plan and Embedded Navigation Tool
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Michigan
Emory Healthcare
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a parallel group, multisite prospective clinical study. The purpose of this study is to evaluate whether ASCENT enables patients to adhere to the survivorship guidelines and improves coordinat...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Age ≥18 years
- Receiving curative intent radiotherapy for prostate cancer (Note: post-operative radiotherapy \[i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy\] is allowed.)
- Subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy.
- Receiving androgen deprivation therapy (ADT) for a duration of ≥3 consecutive months as follows:
- GnRH agonist or antagonist (medical castration), with or without an anti-androgen (i.e., bicalutamide, flutamide, nilutamide, etc.), OR
- Bilateral orchiectomy (surgical castration)
- Technology requirement: candidates must have access to the internet
- Able to understand and willing to sign a written informed consent document.
- Able to speak and understand English, in the opinion of the treating physician.
Exclusion
- Significant concurrent medical or psychiatric condition that would interfere with the patient's ability to abide by the study protocol or cooperate fully with the protocol requirements, including completion of survey and assessment
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2020
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03424837
Start Date
January 11 2019
End Date
November 24 2020
Last Update
July 29 2021
Active Locations (6)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
Emory University & Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065