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

Localized Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717613
• Other study ID #: DLD2007-01
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: January 18, 2018
• Start date: July 2007
• Est. completion date: October 2011

Study information

• Verified date: January 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.

Other known NCT identifiers

• NCT00729066

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life, particularly cancer-specific anxiety and general anxiety		One time retrospective interview