- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03035500
Långtidsuppföljning av patienter med prostatacancer efter operation
Långtidsuppföljning efter prostatacancer
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Correlative studies Ancillary studies
Andra namn:
Ancillary studies Receive health education
Andra namn:
Undergo long-term follow-up using survivorship care plan |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HRQL assessed using Expanded Prostate Cancer Index Composite
Tidsram: 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. |
Up to 10 years
|
|
HRQL assessed using Sexual Health Inventory for Men
Tidsram: 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. |
Up to 10 years
|
|
Incidence rates of the study end-points
Tidsram: 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. |
Up to 10 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Saro Armenian, DO, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Prostatiska neoplasmer
- Undersökningstekniker
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Barnhälsotjänster
- Gemenskapens hälsovård
- Förebyggande hälsovårdstjänster
- Socioekonomiska faktorer
- Befolkningsegenskaper
- Metoder
- Tidig intervention, pedagogisk
- Utbildningsstatus
Andra studie-ID-nummer
- 07101
- 07101 (Annan identifierare: City of Hope Medical Center)
- NCI-2017-00090 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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