Clinical trial NCT03424837: A Survivorship Care Plan and Embedded Navigation Tool
Official title: Evaluation of the Impact of A Survivorship Care Plan and Embedded Navigation Tool (ASCENT) in Patients With Prostate Cancer Undergoing Curative-Intent Radiotherapy With Concurrent Androgen Deprivation Therapy (ADT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Emory Healthcare
name: Johns Hopkins University
name: Memorial Sloan Kettering Cancer Center
name: H. Lee Moffitt Cancer Center and Research Institute
name: UNC Lineberger Comprehensive Cancer Center
name: Morehouse School of Medicine
First posted: 2018-02-07
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 coordination of care to address patient needs.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment.
timeFrame: 6 months
measure: Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial.
timeFrame: 6 months
Secondary outcomes:
measure: General health status
timeFrame: 6 months
measure: Existence and severity of depression
timeFrame: 6 months
measure: Prostate-cancer specific quality of life.
timeFrame: 6 months
measure: Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University & Winship Cancer Institute
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Harrison, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Andrew Peterson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: