This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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:

Further study details as provided by David Latini, 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 ]

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)
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: July 16, 2008
Last Updated: November 7, 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017