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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Emory Healthcare | OTHER |
| Johns Hopkins University | OTHER |
| Memorial Sloan Kettering Cancer Center |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: SoC (standard of care) and ASCENT | Experimental | Health 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASCENT | Behavioral | ASCENT includes the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General health status | General health status will be measured using the EuroQol five dimensions questionnaire (EQ-5D). | 6 months |
| Existence and severity of depression | Existence and severity of depression will be evaluated using the Patient Health Questionnaire (PHQ-9). |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Harrison, M.D. | Duke University | Principal Investigator |
| Andrew Peterson, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States | ||
| Emory University & Winship Cancer Institute |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
| UNC Lineberger Comprehensive Cancer Center | OTHER |
| Morehouse School of Medicine | OTHER |
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|
| 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). | 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). | 6 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Johns Hopkins School of medicine & Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| UNC Lineberger Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |