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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717613
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine

Brief Summary:
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 or disease
Localized Prostate Cancer

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
Study Start Date : July 2007
Primary Completion Date : October 2009
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Observational cohort study

Primary Outcome Measures :
  1. Health-related quality of life, particularly cancer-specific anxiety and general anxiety [ Time Frame: One time retrospective interview ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00717613

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

Responsible Party: David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine Identifier: NCT00717613     History of Changes
Obsolete Identifiers: NCT00729066
Other Study ID Numbers: DLD2007-01
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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