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
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
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Observational cohort study
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Convenience sample of men on active surveillance drawn from large academic medical centers, community hospitals, support groups, and the internet.
- 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.
- 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
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 ClinicalTrials.gov identifier: NCT00717613
|Baylor College of Medicine
|Houston, Texas, United States, 77030 |
Baylor College of Medicine
||David M Latini, PhD
||Baylor College of Medicine
No publications provided
||David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 16, 2008
||November 7, 2011
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male