A Survivorship Care Plan and Embedded Navigation Tool

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: ASCENT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm: SoC (standard of care) and ASCENT<br>Health care per institutional standard plus ASCENT via the TrueNTH website. | Behavioral: ASCENT<br>* 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<br>|
| No Intervention: Control Arm: SoC and TrueNRH<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health status | General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D). | 6 months | 
| Existence and severity of depression | Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9). | 6 months | 
| 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 | 
| 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 |