NCT00012935

Brief Summary

Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Prostate Cancer

Study Arms (1)

Arm 1

OTHER
Behavioral: Help with decision making on prostate cancer treatment

Interventions

Help with decision making on prostate cancer treatmentBEHAVIORAL
Arm 1

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) biopsy confirmed diagnosis of localized prostate cancer; 2) newly diagnosed-no prior treatment (including watchful waiting) or discussion with their prior physicians about treatment options; 3) no previous neoplasms in the last five years, with the exception of basal cell cancer of the skin; 4) speak english; 5) no major psychiatric disorder that would preclude their participation; 6) be between 50 and 80 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Knight SJ, Nathan DP, Siston AK, Kattan MW, Elstein AS, Collela KM, Wolf MS, Slimack NS, Bennett CL, Golub RM. Pilot study of a utilities-based treatment decision intervention for prostate cancer patients. Clin Prostate Cancer. 2002 Sep;1(2):105-14. doi: 10.3816/cgc.2002.n.012.

    PMID: 15046701RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Charles L. Bennett, MD PhD MPP

    Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL

    PRINCIPAL INVESTIGATOR

  • Sara J. Knight, PhD

    Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

December 1, 2001

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)