A Survivorship Care Plan and Embedded Navigation Tool

NCT03424837 | Completed

• 1 other identifier: Pro00088754
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• General health status

  6 months

• Existence and severity of depression

  6 months

• Prostate-cancer specific quality of life.

  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

  6 months

Study Arms (2)

Intervention Arm: SoC (standard of care) and ASCENT

EXPERIMENTAL

Health care per institutional standard plus ASCENT via the TrueNTH website.

Behavioral: ASCENT

Control Arm: SoC and TrueNRH

NO INTERVENTION

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.

Interventions

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

Intervention Arm: SoC (standard of care) and ASCENT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of Michigan: collaborator
• Emory Healthcare: collaborator
• Johns Hopkins University: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• UNC Lineberger Comprehensive Cancer Center: collaborator
• Morehouse School of Medicine: collaborator

Study Sites (6)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Emory University & Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC Lineberger Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Harrison, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Andrew Peterson, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: January 11, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)