A Survivorship Care Plan and Embedded Navigation Tool
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: ASCENT
- Registration Number
- NCT03424837
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 77
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Histologically confirmed diagnosis of prostate adenocarcinoma
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Age ≥18 years
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Receiving curative intent radiotherapy for prostate cancer (Note: post-operative radiotherapy [i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy] is allowed.)
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Subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy.
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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)
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Technology requirement: candidates must have access to the internet
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Able to understand and willing to sign a written informed consent document.
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Able to speak and understand English, in the opinion of the treating physician.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm: SoC (standard of care) and ASCENT ASCENT Health care per institutional standard plus ASCENT via the TrueNTH website.
- Primary Outcome Measures
Name Time Method Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment. 6 months 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.
Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial. 6 months Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT.
- Secondary Outcome Measures
Name Time Method Existence and severity of depression 6 months Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).
Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey 6 months Overall health-related-quality of life will be measured using the Short Form Health Survey (SF-12).
General health status 6 months General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).
Prostate-cancer specific quality of life. 6 months Prostate-cancer specific quality of life will be determined using the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26).
Trial Locations
- Locations (6)
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Emory University & Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
UNC Lineberger Cancer Center
🇺🇸Chapel Hill, North Carolina, United States