Prostate Cancer
Conditions
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
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)
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
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pca Risk-related Knowledge | 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. |
| Pca Perceived Risk | 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. |
| Pca-related Positive Expectations | 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. |
| Negative Expectations Regarding Pca Risk | 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. |
| Pca Related Intrusive Ideation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 128 |
Baseline characteristics
| Characteristic | General Health Education | Cognitive Affective Preparation | Total |
|---|---|---|---|
| Age, Continuous | 47.61 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 participants | 14 participants | 23 participants |
| family history of Pca With positive family history | 58 participants | 47 participants | 105 participants |
| Monitoring attentional style High | 31 participants | 28 participants | 59 participants |
| Monitoring attentional style Low | 36 participants | 33 participants | 69 participants |
| Pca related intrusive ideation | 3.33 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 knowledge | 6.23 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 expectancies | 1.72 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 risk | 3.25 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 expectancies | 3.97 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 33 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 28 Participants | 62 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 67 Participants | 61 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 67 |
| serious Total, serious adverse events | 0 / 61 | 0 / 67 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Negative Expectations Regarding Pca Risk | 2.12 units on a scale | Standard Deviation 0.58 |
| General Health Education | Negative Expectations Regarding Pca Risk | 2.08 units on a scale | Standard Deviation 0.54 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Negative Expectations Regarding Pca Risk | 1.47 units on a scale | Standard Deviation 0.57 |
| General Health Education | Negative Expectations Regarding Pca Risk | 1.53 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Perceived Risk | 3.23 units on a scale | Standard Deviation 0.82 |
| General Health Education | Pca Perceived Risk | 2.98 units on a scale | Standard Deviation 0.82 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Perceived Risk | 2.99 units on a scale | Standard Deviation 0.82 |
| General Health Education | Pca Perceived Risk | 3.13 units on a scale | Standard Deviation 0.83 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Related Intrusive Ideation | 3.64 units on a scale | Standard Deviation 5.97 |
| General Health Education | Pca Related Intrusive Ideation | 3.31 units on a scale | Standard Deviation 5.3 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Related Intrusive Ideation | 3.85 units on a scale | Standard Deviation 4.92 |
| General Health Education | Pca Related Intrusive Ideation | 2.62 units on a scale | Standard Deviation 4.89 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca-related Positive Expectations | 3.66 units on a scale | Standard Deviation 1.16 |
| General Health Education | Pca-related Positive Expectations | 4.07 units on a scale | Standard Deviation 0.79 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca-related Positive Expectations | 3.85 units on a scale | Standard Deviation 1.1 |
| General Health Education | Pca-related Positive Expectations | 3.70 units on a scale | Standard Deviation 0.88 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Risk-related Knowledge | 7.03 units on a scale | Standard Deviation 1.27 |
| General Health Education | Pca Risk-related Knowledge | 7.03 units on a scale | Standard Deviation 1.19 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Affective Preparation | Pca Risk-related Knowledge | 6.92 units on a scale | Standard Deviation 1.02 |
| General Health Education | Pca Risk-related Knowledge | 7.19 units on a scale | Standard Deviation 0.99 |