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Completed

NCT Number: NCT03424837

A Survivorship Care Plan and Embedded Navigation Tool

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASCENT

Behavioral

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

Primary outcomes

  1. 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.

  2. Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial.

    Time frame: 6 months

    Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT.

Secondary outcomes

  1. General health status

    Time frame: 6 months

    General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).

  2. Existence and severity of depression

    Time frame: 6 months

    Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • 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

Registry information

Official study 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)

Acronym: ASCENT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2018
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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