Facilitating Participation in a Prostate Cancer Risk Assessment Program

Temple University Health System (TUHS)

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: General Health Education; Behavioral: Cognitive Affective preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT02126319

TPRB-98-266-01-PBP (Other Grant/Funding Number)

IRB97-811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Male

Ages: 34 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Cognitive Affective Preparation

Experimental group

Description:

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)

Treatment:

Behavioral: Cognitive Affective preparation

General Health Education

Active Comparator group

Description:

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)

Treatment:

Behavioral: General Health Education