Prostate Cancer Clinical Trial
— ASCENTOfficial 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)
Verified date | July 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
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 |
United States,
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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