Facilitating Participation in a Prostate Cancer Risk Assessment Program

Prostate Cancer Clinical Trial

Official title:

Facilitating Participation in a Prostate Cancer Family Risk Assessment Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126319
• Other study ID #: IRB97-811
• Secondary ID: TPRB-98-266-01-P
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: April 28, 2014
• Start date: October 1998
• Est. completion date: April 2002

Study information

• Verified date: April 2014
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to examine whether a cognitive-affective preparation was more beneficial, in general, and more specifically for certain subgroups, such as African-American men and individuals with high monitoring style.

Description:

High risk men enrolling in a state of the science Prostate Cancer Risk Assessment Program (N = 128) underwent a Pca counseling visit immediately followed by either a cognitive-affective preparation (CAP) session designed to help men process the information they received or a general health education session to control for time and attention (comparison group). All men chose to participate in Pca screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 34 Years to 69 Years

Eligibility

Inclusion Criteria:

• Caucasian men, 34 and 69 years of age, at least one first or second degree relative with prostate cancer

OR

• African American men, 35 and 69 years of age

Exclusion Criteria:

• cancer diagnosis

• difficulty communicating in English

• impaired competency to give informed consent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Cognitive Affective preparation
Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate ("pre-live") and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
• General Health Education
A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pca risk-related knowledge		three weeks	No
Primary	Pca perceived risk		three weeks	No
Primary	Pca-related positive expectations		three weeks	No
Primary	negative expectations regarding Pca risk		six months	No
Primary	Pca related intrusive ideation		three weeks	No