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Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00717613
First received: July 16, 2008
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 50
Study Start Date: July 2007
Study Completion Date: October 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Observational cohort study

Detailed Description:

Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the 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

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

No publications provided

Responsible Party: David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00717613     History of Changes
Obsolete Identifiers: NCT00729066
Other Study ID Numbers: DLD2007-01
Study First Received: July 16, 2008
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013