Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2019-01-11
2020-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm: SoC (standard of care) and ASCENT
Health care per institutional standard plus ASCENT via the TrueNTH website.
ASCENT
ASCENT includes the following components:
* Survivorship care plan created through the ASCENT tool
* Online tool which assesses health care needs and facilitates receipt of care
* A national-level navigator who helps the participant to access support services
* Periodic reminders for the participant to pursue recommended survivorship care
Control Arm: SoC and TrueNRH
Health care per institutional standard, plus access to the public information on the TrueNTH website; such as the symptom tracker, exercise \& diet, and lived experiences modules.
No interventions assigned to this group
Interventions
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ASCENT
ASCENT includes the following components:
* Survivorship care plan created through the ASCENT tool
* Online tool which assesses health care needs and facilitates receipt of care
* A national-level navigator who helps the participant to access support services
* Periodic reminders for the participant to pursue recommended survivorship care
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
MALE
No
Sponsors
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University of Michigan
OTHER
Emory Healthcare
OTHER
Johns Hopkins University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER
Morehouse School of Medicine
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Michael Harrison, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Andrew Peterson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Emory University & Winship Cancer Institute
Atlanta, Georgia, United States
Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Lineberger Cancer Center
Chapel Hill, North Carolina, United States
Duke Cancer Institute
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00088754
Identifier Type: -
Identifier Source: org_study_id
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