A Survivorship Care Plan and Embedded Navigation Tool (ASCENT)

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)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: ASCENT

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center & Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University & Winship Cancer Institute
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Cancer Center
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm: SoC (standard of care) and ASCENT; Health care per institutional standard plus ASCENT via the TrueNTH website.	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
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Johns Hopkins University; Memorial Sloan Kettering Cancer Center; University of Michigan; UNC Lineberger Comprehensive Cancer Center; H. Lee Moffitt Cancer Center and Research Institute; Emory Healthcare; Morehouse School of Medicine
• Investigators: Principal Investigator: Michael Harrison, M.D., Duke University; Principal Investigator: Andrew Peterson, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Pro00088754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No