Back to resultsA Survivorship Care Plan and Embedded Navigation Tool (ASCENT)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASCENT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
- Emory University & Winship Cancer Institute
- Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- UNC Lineberger Cancer Center
- Duke Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm: SoC (standard of care) and ASCENT
Control Arm: SoC and TrueNRH
Arm Description
Health care per institutional standard plus ASCENT via the TrueNTH website.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
General health status
General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).
Existence and severity of depression
Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).
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).
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).
Full Information
NCT ID
NCT03424837
First Posted
January 26, 2018
Last Updated
July 23, 2021
Sponsor
Duke University
Collaborators
University of Michigan, Emory Healthcare, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, H. Lee Moffitt Cancer Center and Research Institute, UNC Lineberger Comprehensive Cancer Center, Morehouse School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03424837
Brief Title
A Survivorship Care Plan and Embedded Navigation Tool
Acronym
ASCENT
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
November 24, 2020 (Actual)
Study Completion Date
November 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of Michigan, Emory Healthcare, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, H. Lee Moffitt Cancer Center and Research Institute, UNC Lineberger Comprehensive Cancer Center, Morehouse School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm: SoC (standard of care) and ASCENT
Arm Type
Experimental
Arm Description
Health care per institutional standard plus ASCENT via the TrueNTH website.
Arm Title
Control Arm: SoC and TrueNRH
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ASCENT
Intervention Description
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 Outcome Measure Information:
Title
Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment.
Description
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.
Time Frame
6 months
Title
Assess trial participants', caregivers'/family members', and staff satisfaction and experiences with the ASCENT technology and trial.
Description
Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
General health status
Description
General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).
Time Frame
6 months
Title
Existence and severity of depression
Description
Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).
Time Frame
6 months
Title
Prostate-cancer specific quality of life.
Description
Prostate-cancer specific quality of life will be determined using the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26).
Time Frame
6 months
Title
Overall health-related-quality of life including, but not limited to, mental and physical functioning as measured by the Short Form Health Survey
Description
Overall health-related-quality of life will be measured using the Short Form Health Survey (SF-12).
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harrison, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Peterson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University & Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
UNC Lineberger Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Survivorship Care Plan and Embedded Navigation Tool
We'll reach out to this number within 24 hrs