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

NCT00717613 | Completed

• 1 other identifier: DLD2007-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life, particularly cancer-specific anxiety and general anxiety

  One time retrospective interview

Study Arms (1)

1

Observational cohort study

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \) female
• \) no diagnosis of localized prostate cancer
• \) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
• \) no phone or US mail address
• \) unwilling or unable to provide informed consent
• \) unable to speak and understand English

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

• David M Latini, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor of Urology

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2011
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)