Long-term Follow-up After Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,500
- Locations
- 2
- Primary Endpoint
- HRQL assessed using Sexual Health Inventory for Men
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician
Exclusion Criteria
- •Current treatment with testosterone replacement or androgen deprivation therapy
- •Treatment for another noncutaneous cancer within the past 2 years
Arms & Interventions
Supportive Care (long-term follow-up)
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.
Intervention: Questionnaire Administration (Other)
Supportive Care (long-term follow-up)
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.
Intervention: Laboratory Biomarker Analysis (Other)
Supportive Care (long-term follow-up)
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.
Intervention: Quality-of-Life Assessment (Other)
Supportive Care (long-term follow-up)
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.
Intervention: Long-term Follow-up (Other)
Supportive Care (long-term follow-up)
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.
Intervention: Educational Intervention (Other)
Outcomes
Primary Outcomes
HRQL assessed using Sexual Health Inventory for Men
Time Frame: Up to 10 years
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
HRQL assessed using Expanded Prostate Cancer Index Composite
Time Frame: Up to 10 years
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
Incidence rates of the study end-points
Time Frame: Up to 10 years
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.
Secondary Outcomes
No secondary outcomes reported