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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00090 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 07101 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.
PRIMARY OBJECTIVES:
I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.
II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.
III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.
OUTLINE:
Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (long-term follow-up) | Experimental | Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive health education |
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| Measure | Description | Time Frame |
|---|---|---|
| HRQL assessed using Expanded Prostate Cancer Index Composite | Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. | Up to 10 years |
| HRQL assessed using Sexual Health Inventory for Men | Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. | Up to 10 years |
| Incidence rates of the study end-points | Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. | Up to 10 years |
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Inclusion Criteria:
Diagnosis of prostate cancer
Treated with a definitive surgical procedure at City of Hope
At least one year post surgical treatment for prostate cancer
No history of recurrent, progressive, or metastatic disease
Currently stable disease or no evidence of disease
No prior treatment of prostate cancer with radiation or chemotherapy
No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saro Armenian, DO | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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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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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Long-term Follow-up | Other | Undergo long-term follow-up using survivorship care plan |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |