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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00815750
First received: December 29, 2008
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Prostate Cancer
Other: Information Gathering
Other: Decision Aid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Aim #1 Formative, Phase 1 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Aim #2 Pilot Intervention, Phase 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To assess the feasibility, acceptability and preliminary efficacy of the enhanced decision aids for first degree relatives of prostate cancer patients.


Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phase I - Information Gathering Other: Information Gathering
An information gathering phase leading to development of a new decision aid.
Phase 2 - Decision Aid Other: Decision Aid
To test the newly developed decision aid.

Detailed Description:

Phase 1 - The purpose of this part of the research study is to conduct individual interviews and focus groups (group discussions) to learn more about the things or behaviors that help men to stay healthy and the decision making process for prostate cancer screening. We will discuss men's general health concerns, knowledge, beliefs, and concerns regarding prostate cancer and screening for prostate cancer. We will use the results from this study to develop a decision aid to help first-degree relatives of prostate cancer patients make informed decisions about whether to undergo testing or not to undergo testing for prostate cancer. The new decision aid will include a digital videodisc (DVD) and an accompanying booklet. We hope to learn from you the needs and concerns of first-degree relatives, what information to include in the decision aid, what language to use, and the best way to present this information.

Phase 2 - The purpose of this part of the research study is to test the usefulness and acceptability of a new decision aid we developed specifically for first-degree relatives (FDRs) of prostate cancer patients. We will compare the new decision aid to another widely available decision aid that was not developed specifically for first-degree relatives. The goal is to see if the new decision aid will change knowledge (about prostate cancer and screening) and increase satisfaction with decision making (intention or decision made). If we find some evidence that the new decision aid is relevant (useful) and acceptable, we will then do a larger study with several hundred men to determine more definitively whether the new decision aid is better than already existing general decision materials and for which men it works best.

Because the correct decision (whether to undergo screening or not to undergo screening) is not known at this time, the goal of decision aids is to present both (in a balanced manner) the potential harms and benefits of screening. Therefore, this study focuses on the informed decision making (knowledge and satisfaction with decision).

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/Exclusion Criteria:

  • 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.
  • Unaffected FDRs - Inclusion criteria for FDRs includes: (a) be non-Hispanic African American or White males between the ages of 40 and 70; (b) have no self-reported history of a diagnosis of any form of cancer (excluding non-melanoma skin cancer), (c) have no self-reported history of prostate biopsy, or transrectal ultrasound to investigate or rule out diagnosis of prostate cancer; (d) have not participated in the phase (formative) portion of this study (i.e., must be "naïve" to the intervention); (e) be able to speak, read and write English; (f) self-report access to a DVD player; and (g) be able to provide written informed consent. FDRs with a relative in active definitive prostate cancer treatment (i.e., surgery, radiotherapy or chemotherapy, except for hormone therapy) or who has completed treatment in the past 30 days will not be eligible. FDRs with multiple living relatives who been diagnosed with prostate cancer will be excluded to reduce heterogeneity of our phase 2 sample; this exclusion criterion is expected to have a minimal influence on accrual in light of our previous data on the percentage of men with multiple affected relatives (less than 5%).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815750

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
James A. Haley VA Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Clement Gwede H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00815750     History of Changes
Other Study ID Numbers: MCC-15320, 106302
Study First Received: December 29, 2008
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014