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Facilitating Participation in a Prostate Cancer Risk Assessment Program

Facilitating Participation in a Prostate Cancer Family Risk Assessment Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02126319
Enrollment
128
Registered
2014-04-30
Start date
1998-10-31
Completion date
2002-04-30
Last updated
2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Cognitive-affective preparation, prostate cancer counseling

Brief 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.

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.

Interventions

BEHAVIORALCognitive 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)

BEHAVIORALGeneral 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)

Sponsors

Fox Chase Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
34 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pca Risk-related Knowledgethree weeksKnowledge 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.
Pca Perceived Riskthree weeksPerceived 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.
Pca-related Positive Expectationsthree weeksPositive 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.
Negative Expectations Regarding Pca Riskthree weeksNegative 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.
Pca Related Intrusive Ideationthree weeksIntrusive 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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)
61
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)
67
Total128

Baseline characteristics

CharacteristicGeneral Health EducationCognitive Affective PreparationTotal
Age, Continuous47.61 years
STANDARD_DEVIATION 8.81
47.21 years
STANDARD_DEVIATION 8.86
47.42 years
STANDARD_DEVIATION 8.8
family history of Pca
No family history
9 participants14 participants23 participants
family history of Pca
With positive family history
58 participants47 participants105 participants
Monitoring attentional style
High
31 participants28 participants59 participants
Monitoring attentional style
Low
36 participants33 participants69 participants
Pca related intrusive ideation3.33 units on a scale
STANDARD_DEVIATION 4.32
4.51 units on a scale
STANDARD_DEVIATION 5.81
3.89 units on a scale
STANDARD_DEVIATION 5.1
Pca related knowledge6.23 units on a scale
STANDARD_DEVIATION 1.39
6.53 units on a scale
STANDARD_DEVIATION 1.4
6.37 units on a scale
STANDARD_DEVIATION 1.4
Pca related negative expectancies1.72 units on a scale
STANDARD_DEVIATION 0.78
1.72 units on a scale
STANDARD_DEVIATION 0.78
1.72 units on a scale
STANDARD_DEVIATION 0.78
Pca related perceived risk3.25 units on a scale
STANDARD_DEVIATION 0.77
3.10 units on a scale
STANDARD_DEVIATION 0.87
3.18 units on a scale
STANDARD_DEVIATION 0.82
Pca related positive expectancies3.97 units on a scale
STANDARD_DEVIATION 0.91
3.86 units on a scale
STANDARD_DEVIATION 1.09
3.92 units on a scale
STANDARD_DEVIATION 0.99
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
33 Participants33 Participants66 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
34 Participants28 Participants62 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
67 Participants61 Participants128 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 610 / 67
serious
Total, serious adverse events
0 / 610 / 67

Outcome results

Primary

Negative Expectations Regarding Pca Risk

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.

Time frame: Six months

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationNegative Expectations Regarding Pca Risk2.12 units on a scaleStandard Deviation 0.58
General Health EducationNegative Expectations Regarding Pca Risk2.08 units on a scaleStandard Deviation 0.54
Primary

Negative Expectations Regarding Pca Risk

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.

Time frame: three weeks

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationNegative Expectations Regarding Pca Risk1.47 units on a scaleStandard Deviation 0.57
General Health EducationNegative Expectations Regarding Pca Risk1.53 units on a scaleStandard Deviation 0.7
Primary

Pca Perceived Risk

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.

Time frame: three weeks

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Perceived Risk3.23 units on a scaleStandard Deviation 0.82
General Health EducationPca Perceived Risk2.98 units on a scaleStandard Deviation 0.82
Primary

Pca Perceived Risk

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.

Time frame: six months

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Perceived Risk2.99 units on a scaleStandard Deviation 0.82
General Health EducationPca Perceived Risk3.13 units on a scaleStandard Deviation 0.83
Primary

Pca Related Intrusive Ideation

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.

Time frame: three weeks

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Related Intrusive Ideation3.64 units on a scaleStandard Deviation 5.97
General Health EducationPca Related Intrusive Ideation3.31 units on a scaleStandard Deviation 5.3
Primary

Pca Related Intrusive Ideation

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.

Time frame: Six months

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Related Intrusive Ideation3.85 units on a scaleStandard Deviation 4.92
General Health EducationPca Related Intrusive Ideation2.62 units on a scaleStandard Deviation 4.89
Primary

Pca-related Positive Expectations

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.

Time frame: three weeks

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca-related Positive Expectations3.66 units on a scaleStandard Deviation 1.16
General Health EducationPca-related Positive Expectations4.07 units on a scaleStandard Deviation 0.79
Primary

Pca-related Positive Expectations

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.

Time frame: six months

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca-related Positive Expectations3.85 units on a scaleStandard Deviation 1.1
General Health EducationPca-related Positive Expectations3.70 units on a scaleStandard Deviation 0.88
Primary

Pca Risk-related Knowledge

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.

Time frame: six months

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Risk-related Knowledge7.03 units on a scaleStandard Deviation 1.27
General Health EducationPca Risk-related Knowledge7.03 units on a scaleStandard Deviation 1.19
Primary

Pca Risk-related Knowledge

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.

Time frame: three weeks

ArmMeasureValue (MEAN)Dispersion
Cognitive Affective PreparationPca Risk-related Knowledge6.92 units on a scaleStandard Deviation 1.02
General Health EducationPca Risk-related Knowledge7.19 units on a scaleStandard Deviation 0.99

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026