Prostate CancerASCENTNCT03424837
A Survivorship Care Plan and Embedded Navigation Tool
A study testing ASCENT in people with Prostate Cancer, run by Duke University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ASCENT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jan 2019to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University & Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
UNC Lineberger Cancer Center
Chapel Hill, North Carolina, 27599
Duke Cancer Institute
Durham, North Carolina, 27710
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
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)
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
- Being tested
- ASCENT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCENTBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: SoC (standard of care) and ASCENT | Experimental | Health care per institutional standard plus ASCENT via the TrueNTH website. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
General health status
General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D).
Measured: 6 months
Existence and severity of depression
Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start11 Jan 2019
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Michael Harrison, M.D., Principal investigator, Duke UniversityAndrew Peterson, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424837
- Sponsor's protocol ID
- Pro00088754
- Acronym
- ASCENT
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2018
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03424837
- Acronym / sponsor ID
- ASCENT / Pro00088754
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- 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
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: SoC (standard of care) and ASCENT | Experimental | Behavioral: ASCENTHealth care per institutional standard plus ASCENT via the TrueNTH website. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCENTASCENT 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 | Behavioural | Intervention Arm: SoC (standard of care) and ASCENT |
Primary outcome
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.
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.
4 secondary outcomes
General health status
Time frame: 6 months
Existence and severity of depression
Time frame: 6 months
Prostate-cancer specific quality of life.
Time frame: 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
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harrison, M.D. principal investigator
Duke University
Andrew Peterson, M.D. principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASCENT in people with Prostate Cancer, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.