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Completed

NCT Number: NCT02126319

Facilitating Participation in a Prostate Cancer 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.

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Key information

Age range

34 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

Facilitating Participation in a Prostate Cancer Family Risk Assessment Program

Important dates

Study start
1998
Primary completion
2002
Study completion
2002
First posted
Apr 30, 2014
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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