A Survivorship Care Plan and Embedded Navigation Tool

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Intervention Arm: SoC and ASCENT
    • Health care per institutional standard plus ASCENT via the TrueNTH website.
  • No Intervention: Control Arm: SoC and TrueNRH
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment.
    • Time Frame: 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.

Secondary Measures

  • General health status
    • Time Frame: 6 months
    • General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).
  • Existence and severity of depression
    • Time Frame: 6 months
    • Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).
  • Prostate-cancer specific quality of life.
    • Time Frame: 6 months
    • Prostate-cancer specific quality of life will be determined using the Expanded Prostate Cancer Index Composite – Short Form (EPIC-26).
  • Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey
    • Time Frame: 6 months
    • Overall health-related-quality of life will be measured using the Short Form Health Survey (SF-12).

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Harrison, M.D., Principal Investigator, Duke University
    • Andrew Peterson, M.D., Principal Investigator, Duke University

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