Facilitating Participation in a Prostate Cancer Risk Assessment Program

NCT02126319 | Completed Results

• 2 other identifiers: IRB97-811TPRB-98-266-01-PBP
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Cognitive-affective preparation; prostate cancer counseling

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Study Arms (2)

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)

Behavioral: Cognitive Affective preparation

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)

Behavioral: General Health Education

Interventions

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)

Cognitive Affective Preparation

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)

General Health Education

Eligibility Criteria

• Age: 34 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian men, 34 and 69 years of age, at least one first or second degree relative with prostate cancer
• African American men, 35 and 69 years of age

You may not qualify if:

• cancer diagnosis
• difficulty communicating in English
• impaired competency to give informed consent.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Suzanne M. Miller
• Organization: Fox Chase Cancer Center

Suzanne.Miller@fccc.edu

215 728-4069

Study Officials

• Suzanne M Miller, Ph.D.

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 30, 2014
• Study Start: October 1, 1998
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)