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Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
This study is currently recruiting participants.
Verified by Baylor College of Medicine, July 2008
Sponsored by: Baylor College of Medicine
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00717613
  Purpose

This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.


Condition
Localized Prostate Cancer

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Cross-Sectional
Official Title: Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Health-related quality of life, particularly cancer-specific anxiety and general anxiety [ Time Frame: One time retrospective interview ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Study Completion Date: June 2008
Groups/Cohorts
1
Observational cohort study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Convenience sample of men on active surveillance drawn from large academic medical centers, community hospitals, support groups, and the internet.

Criteria

Inclusion Criteria:

  • 1) male,
  • 2) 18 years or older, with biopsy-proven prostate cancer,
  • 3) diagnosed with localized disease within the last 24 months,
  • 4) have a telephone at the time of enrollment,
  • 5) have an address where they can receive study materials by mail (a street address or post office box),
  • 6) able to speak and understand English;
  • 7) have selected surveillance, rather than active treatment for his prostate cancer.

Exclusion Criteria:

  • 1) female
  • 2) no diagnosis of localized prostate cancer
  • 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
  • 4) no phone or US mail address
  • 5) unwilling or unable to provide informed consent
  • 6) unable to speak and understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717613

Contacts
Contact: David M Latini, PhD 1-877-794-7852 CancerOutcomes@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David M Latini, PhD            
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: David M Latini, PhD Baylor College of Medicine
  More Information

Responsible Party: Baylor College of Medicine ( David M. Latini, PhD )
Study ID Numbers: DLD2007-01
Study First Received: July 16, 2008
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00717613  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009