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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424837
Other study ID # Pro00088754
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2019
Est. completion date November 24, 2020

Study information

Verified date July 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date November 24, 2020
Est. primary completion date November 24, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
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 UNC Lineberger Cancer Center Chapel Hill North Carolina
United States Duke Cancer Institute Durham North Carolina
United States Memorial Sloan Kettering Cancer Center New York New York
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (8)

Lead Sponsor Collaborator
Duke University Emory Healthcare, H. Lee Moffitt Cancer Center and Research Institute, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, Morehouse School of Medicine, UNC Lineberger Comprehensive Cancer Center, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment. Abiding by the survivorship guidelines is defined as either of: Making an appointment with primary health care provider within 6 months of enrollment, OR completing a guideline-based assessment or management strategy for reducing side effects related to prostate cancer treatment. 6 months
Primary Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial. Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT. 6 months
Secondary General health status General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D). 6 months
Secondary Existence and severity of depression Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9). 6 months
Secondary Prostate-cancer specific quality of life. Prostate-cancer specific quality of life will be determined using the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26). 6 months
Secondary Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey Overall health-related-quality of life will be measured using the Short Form Health Survey (SF-12). 6 months
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