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

NCT ID: NCT00717613

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-10-31

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.

Conditions

Localized Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Observational cohort study

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

David Latini

Adjunct Assistant Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Latini, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

DLD2007-01

Identifier Type: -

Identifier Source: org_study_id

NCT00729066

Identifier Type: -

Identifier Source: nct_alias