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

Completed

• Conditions: Localized Prostate Cancer

• Registration Number: NCT00717613
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Primary Completion: 2009-10
• Study Completion: 2011-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life, particularly cancer-specific anxiety and general anxiety	One time retrospective interview

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States