Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients

NCT00815750 | Completed

• 2 other identifiers: MCC-15320106302
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

Brief Summary

There are two parts to this study: (1) an information gathering phase leading to development of a new decision aid (phase 1); and (2) a study to test the newly developed decision aid (phase 2).

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Aim #1 Formative, Phase 1

  To assess and enhance the Centers for Disease Control and Prevention (CDC)prostate cancer screening decision guides into targeted informed decision aids developed specifically for first-degree relatives of prostate cancer patients.

  1 day

Secondary Outcomes (1)

• Aim #2 Pilot Intervention, Phase 2

  1 year

Study Arms (2)

Phase I - Information Gathering

OTHER

Other: Information Gathering

Phase 2 - Decision Aid

OTHER

Other: Decision Aid

Interventions

Information Gathering OTHER

An information gathering phase leading to development of a new decision aid.

Phase I - Information Gathering

Decision Aid OTHER

To test the newly developed decision aid.

Phase 2 - Decision Aid

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Index Patients - African American and White (non-Hispanic) index patients who have completed definitive treatment for prostate cancer will be approached to participate.
• Index Patients Must: (a) reside in the tri-county Tampa Bay area (Hillsborough, Pinellas and Pasco Counties, FL) to simplify logistics of arranging face-to-face focus groups; (b) be willing to attend a focus group; (c) be able to speak, read and write in English; and (d) be able to provide written informed consent.
• Index patients will be asked to nominate at least one male FDR (son or brother) with no history of prostate cancer.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

James A. Haley VA Hospital

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Clement Gwede

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (2)