Prostate Cancer
Conditions
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.
Interventions
BEHAVIORALASCENT
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
Sponsors
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
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abiding by the survivorship guidelines as measured by making an appointment within 6 months of enrollment OR completing a guideline-based assessment. | 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. | 6 months | Focus group comments and question responses detailing trial participants', caregivers'/family members', and staff's satisfaction and experiences with ASCENT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General health status | 6 months | General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D). |
| Existence and severity of depression | 6 months | Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9). |
| Prostate-cancer specific quality of life. | 6 months | 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 | 6 months | Overall health-related-quality of life will be measured using the Short Form Health Survey (SF-12). |
Countries
United States
Outcome results
None listed