Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TPRB-98-266-01-PBP | Other Grant/Funding Number | American Cancer Society |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Affective Preparation | Experimental | 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 | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Affective preparation | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | three weeks |
| 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. | three weeks |
| 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. | three weeks |
| 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. |
Not provided
Not provided
Inclusion Criteria:
OR
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suzanne M Miller, Ph.D. | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
Between October 1998 and April 2002. Six months follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzanne M. Miller | Fox Chase Cancer Center | 215 728-4069 | Suzanne.Miller@fccc.edu |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| General Health Education | Behavioral | 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) |
|
| three weeks |
| 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. | three weeks |
| 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. | six months |
| 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. | six months |
| 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. | six months |
| 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. | Six months |
| 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. | Six months |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| family history of Pca | Baseline information regarding family history for prostate cancer was incomplete. A man was considered as having a positive family history for prostate cancer if Data at baseline was incomplete regarding this variable (20 men for the General Health Education Group and 16 men for the Cognitive Affective Preparation Group). | Number | participants |
|
| Pca 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 DRE and/or 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, with higher values indicating higher knwoledge. | Mean | Standard Deviation | units on a scale |
|
| Pca related 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. Higher scores indicate higher Pca perceived risk i.e. 1=much lower risk; 5=much higher risk. Cronbach's alpha for the scale was 0.83. | Mean | Standard Deviation | units on a scale |
|
| Pca related positive expectancies | Positive expectancies 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 prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five. Higher scores indicate more Pca related positive expectancies. Cronbach's alpha for the scale was 0.76. | Mean | Standard Deviation | units on a scale |
|
| Pca related negative expectancies | Negative expectancies 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 prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five. Higher scores indicate more negative expectancies. Cronbach's alpha for the scale was 0.80. | Mean | Standard Deviation | units on a scale |
|
| Pca related intrusive ideation | Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). This instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Only the intrusive ideation subscale was used in this study. The range of possible values is 0 to 35. Higher scores indicate 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 and a low group. | Mean | Standard Deviation | units on a scale |
|
| Monitoring attentional style | Monitoring attentional style was assessed at baseline using the Monitoring Style Subscale (MBSS; Miller, 1987), which measures attentional responses to four structured stress-evoking scenarios. Each scenario is followed by four possible monitoring responses. Participants endorse all the responses that apply to them. A total monitoring score (range 0-16) is computed for each participant by summing the number of monitoring responses endorsed within each of the four scenarios. A median split was used to create a high (greater than 9) and a low (less or equal to 9) monitoring group. | Number | participants |
|
| OG001 | 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) |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | three weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | six months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | six months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | six months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Six months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Six months |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | 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) | 0 | 67 | 0 | 67 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |