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

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.

Study Overview

• Status: Completed
• Conditions: Localized Prostate Cancer

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Observational cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health-related quality of life, particularly cancer-specific anxiety and general anxiety	One time retrospective interview

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: David M Latini, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: DLD2007-01