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Trial record 64 of 2745 for:    prostate cancer AND Cancer | ( Map: United States )

Facilitating Participation in a Prostate Cancer Risk Assessment Program

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ClinicalTrials.gov Identifier: NCT02126319
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Cognitive Affective preparation Behavioral: General Health Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Facilitating Participation in a Prostate Cancer Family Risk Assessment Program
Study Start Date : October 1998
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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)
Behavioral: 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)

Active Comparator: 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)
Behavioral: 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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126319


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
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Principal Investigator: Suzanne M Miller, Ph.D. Fox Chase Cancer Center

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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT02126319     History of Changes
Other Study ID Numbers: IRB97-811
TPRB-98-266-01-PBP ( Other Grant/Funding Number: American Cancer Society )
First Posted: April 30, 2014    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fox Chase Cancer Center:
Cognitive-affective preparation
prostate cancer counseling
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases