- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126319
Facilitating Participation in a Prostate Cancer Risk Assessment Program
February 21, 2017 updated by: Fox Chase Cancer Center
Facilitating Participation in a Prostate Cancer Family Risk Assessment Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
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)
|
Active Comparator: 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)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pca Risk-related Knowledge
Time Frame: three weeks
|
Knowledge about Pca risk was measured using an eight item scale prepared for this study.
It consisted of true/false items [e.g., "An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer"].
Correct responses received a value of one, whereas false responses received a zero.
Values ranged between zero and eight.
Higher score means better knowledge of risk and issues.
|
three weeks
|
Pca Perceived Risk
Time Frame: three weeks
|
Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., "Do you feel as though you are the kind of person who is likely to develop prostate cancer?") or comparing themselves to other men at risk for Pca (e.g., "Given your ethnicity, what are your chance of getting prostate cancer?") on a five-point scale (Lerman et al., 1996).
Reported means are based on a scale from one to five (based on the average of the four items).
Cronbach's alpha for the scale was 0.83.
A higher score indicates higher Pca perceived risk.
|
three weeks
|
Pca-related Positive Expectations
Time Frame: three weeks
|
Positive expectations regarding the effects of screening were assessed using two items on a five-point scale ("Regular screening will ensure that I stay healthy" and "Regular screening will prolong my life").
Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996).
Reported means are based on a scale from one to five (average of the two items).
Cronbach's alpha for the scale was 0.76.
Higher score indicates more positive expectations.
|
three weeks
|
Negative Expectations Regarding Pca Risk
Time Frame: three weeks
|
Negative expectations related to Pca screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., "Screening may have a negative impact on my health insurance").
Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996).
Reported means are based on a scale from one to five (average of five items).
Cronbach's alpha for the scale was 0.80.
A higher score indicates more negative expectations.
|
three weeks
|
Pca Related Intrusive Ideation
Time Frame: three weeks
|
Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979).
The full scale consists of two subscales, intrusive ideation and avoidant ideation.
In this study only the intrusive ideation subscale was used.
The instrument has been used extensively in the cancer literature (Schwartz et al., 2002).
Values range from 0 to 35, with higher values indicating a higher level of intrusive ideation.
Cronbach's alpha for the intrusion subscale in the present study was 0.82.
Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.
|
three weeks
|
Pca Risk-related Knowledge
Time Frame: six months
|
Knowledge about Pca risk was measured using an eight item scale prepared for this study.
It consisted of true/false items [e.g., "An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer"].
Correct responses received a value of one, whereas false responses received a zero.
Values ranged between zero and eight.
Higher score means better knowledge of risk and issues.
|
six months
|
Pca Perceived Risk
Time Frame: six months
|
Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., "Do you feel as though you are the kind of person who is likely to develop prostate cancer?") or comparing themselves to other men at risk for Pca (e.g., "Given your ethnicity, what are your chance of getting prostate cancer?") on a five-point scale (Lerman et al., 1996).
Reported means are based on a scale from one to five (based on the average of the four items).
Cronbach's alpha for the scale was 0.83.
A higher score indicates higher Pca perceived risk.
|
six months
|
Pca-related Positive Expectations
Time Frame: six months
|
Positive expectations regarding the effects of screening were assessed using two items on a five-point scale ("Regular screening will ensure that I stay healthy" and "Regular screening will prolong my life").
Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996).
Reported means are based on a scale from one to five (average of the two items).
Cronbach's alpha for the scale was 0.76.
Higher score indicates more positive expectations.
|
six months
|
Negative Expectations Regarding Pca Risk
Time Frame: Six months
|
Negative expectations related to Pca risk screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., "Screening may have a negative impact on my health insurance").
Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996).
Reported means are based on a scale from one to five (average of five items).
Cronbach's alpha for the scale was 0.80.
A higher score indicates more negative expectations.
|
Six months
|
Pca Related Intrusive Ideation
Time Frame: Six months
|
Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979).
The full scale consists of two subscales, intrusive ideation and avoidant ideation but only the intrusive ideation subscale was used in the present study.
The instrument has been used extensively in the cancer literature (Schwartz et al., 2002).
Cronbach's alpha for the intrusion subscale in the present study was 0.82.
Values range from zero to 35, with higher values indicating higher level of intrusive ideation.
Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne M Miller, Ph.D., Fox Chase Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1998
Primary Completion (Actual)
April 1, 2002
Study Completion (Actual)
April 1, 2002
Study Registration Dates
First Submitted
March 24, 2014
First Submitted That Met QC Criteria
April 28, 2014
First Posted (Estimate)
April 30, 2014
Study Record Updates
Last Update Posted (Actual)
April 6, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB97-811
- TPRB-98-266-01-PBP (Other Grant/Funding Number: American Cancer Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Cognitive Affective preparation
-
Fox Chase Cancer CenterNational Cancer Institute (NCI); Temple UniversityCompletedUterine Cervical NeoplasmsUnited States
-
National Institute of Diabetes and Digestive and...The Miriam HospitalCompletedObesity | OverweightUnited States
-
Groupe Hospitalier de la Region de Mulhouse et...Recruiting
-
The University of Texas at San AntonioRecruitingAnger | Aggression | Emotional Distress | Violence | Intermittent Explosive DisorderUnited States
-
Mayo ClinicNational Eating Disorders AssociationCompletedEmotional Disorder | Eating DisorderUnited States
-
University of MinnesotaNeuropsychiatric Research Institute, Fargo, North DakotaCompletedBinge Eating DisorderUnited States
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedMedication Adherence | Acute Coronary Syndrome | FearUnited States
-
University of South-Eastern NorwayCompleted
-
Rutgers, The State University of New JerseyNational Institute of Mental Health (NIMH)CompletedSomatization DisorderUnited States
-
The University of Texas at San AntonioActive, not recruiting