Trial Outcomes & Findings for Facilitating Participation in a Prostate Cancer Risk Assessment Program (NCT NCT02126319)

Last Updated: 2017-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

128 participants

Primary outcome timeframe

three weeks

Results posted on

2017-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	61	67
Overall Study COMPLETED	40	43
Overall Study NOT COMPLETED	21	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Facilitating Participation in a Prostate Cancer Risk Assessment Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Affective Preparation n=61 Participants 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 n=67 Participants 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)	Total n=128 Participants Total of all reporting groups
Age, Continuous	47.21 years STANDARD_DEVIATION 8.86 • n=5 Participants	47.61 years STANDARD_DEVIATION 8.81 • n=7 Participants	47.42 years STANDARD_DEVIATION 8.80 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	67 Participants n=7 Participants	128 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	34 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
family history of Pca With positive family history	47 participants n=5 Participants	58 participants n=7 Participants	105 participants n=5 Participants
family history of Pca No family history	14 participants n=5 Participants	9 participants n=7 Participants	23 participants n=5 Participants
Pca related knowledge	6.53 units on a scale STANDARD_DEVIATION 1.40 • n=5 Participants	6.23 units on a scale STANDARD_DEVIATION 1.39 • n=7 Participants	6.37 units on a scale STANDARD_DEVIATION 1.40 • n=5 Participants
Pca related perceived risk	3.10 units on a scale STANDARD_DEVIATION 0.87 • n=5 Participants	3.25 units on a scale STANDARD_DEVIATION 0.77 • n=7 Participants	3.18 units on a scale STANDARD_DEVIATION 0.82 • n=5 Participants
Pca related positive expectancies	3.86 units on a scale STANDARD_DEVIATION 1.09 • n=5 Participants	3.97 units on a scale STANDARD_DEVIATION 0.91 • n=7 Participants	3.92 units on a scale STANDARD_DEVIATION 0.99 • n=5 Participants
Pca related negative expectancies	1.72 units on a scale STANDARD_DEVIATION 0.78 • n=5 Participants	1.72 units on a scale STANDARD_DEVIATION 0.78 • n=7 Participants	1.72 units on a scale STANDARD_DEVIATION 0.78 • n=5 Participants
Pca related intrusive ideation	4.51 units on a scale STANDARD_DEVIATION 5.81 • n=5 Participants	3.33 units on a scale STANDARD_DEVIATION 4.32 • n=7 Participants	3.89 units on a scale STANDARD_DEVIATION 5.10 • n=5 Participants
Monitoring attentional style High	28 participants n=5 Participants	31 participants n=7 Participants	59 participants n=5 Participants
Monitoring attentional style Low	33 participants n=5 Participants	36 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: three weeks

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=38 Participants 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 n=42 Participants 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)
Pca Risk-related Knowledge	6.92 units on a scale Standard Deviation 1.02	7.19 units on a scale Standard Deviation 0.99

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=42 Participants 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 n=46 Participants 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)
Pca Perceived Risk	3.23 units on a scale Standard Deviation 0.82	2.98 units on a scale Standard Deviation 0.82

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=42 Participants 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 n=49 Participants 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)
Pca-related Positive Expectations	3.66 units on a scale Standard Deviation 1.16	4.07 units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=41 Participants 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 n=49 Participants 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)
Negative Expectations Regarding Pca Risk	1.47 units on a scale Standard Deviation 0.57	1.53 units on a scale Standard Deviation 0.70

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=42 Participants 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 n=48 Participants 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)
Pca Related Intrusive Ideation	3.64 units on a scale Standard Deviation 5.97	3.31 units on a scale Standard Deviation 5.30

PRIMARY outcome

Timeframe: six months

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=39 Participants 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 n=40 Participants 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)
Pca Risk-related Knowledge	7.03 units on a scale Standard Deviation 1.27	7.03 units on a scale Standard Deviation 1.19

PRIMARY outcome

Timeframe: six months

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=39 Participants 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 n=40 Participants 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)
Pca Perceived Risk	2.99 units on a scale Standard Deviation .82	3.13 units on a scale Standard Deviation .83

PRIMARY outcome

Timeframe: six months

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=40 Participants 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 n=45 Participants 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)
Pca-related Positive Expectations	3.85 units on a scale Standard Deviation 1.10	3.70 units on a scale Standard Deviation 0.88

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=39 Participants 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 n=44 Participants 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)
Negative Expectations Regarding Pca Risk	2.12 units on a scale Standard Deviation .58	2.08 units on a scale Standard Deviation 0.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Affective Preparation n=39 Participants 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 n=45 Participants 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)
Pca Related Intrusive Ideation	3.85 units on a scale Standard Deviation 4.92	2.62 units on a scale Standard Deviation 4.89

Adverse Events

Cognitive Affective Preparation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suzanne M. Miller

Fox Chase Cancer Center

Phone: 215 728-4069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place