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Trial record 32 of 2746 for:    prostate cancer AND Cancer | ( Map: United States )

Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

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ClinicalTrials.gov Identifier: NCT02419846
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Other: Educational Intervention Procedure: digital rectal examination Other: Pre-test administration Other: Survey Administration Other: Prostate-specific antigen measurement Other: Post test administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18

OUTLINE:

Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

After completion of study, participants are followed up periodically.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Men over 40: Screening with intervention
Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
Other: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Other Names:
  • PowerPoint Presentation
  • Intervention, Educational

Procedure: digital rectal examination
Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening
Other Name: DRE

Other: Pre-test administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Other Name: questionnaire administration

Other: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Other Name: Program Evaluation

Other: Prostate-specific antigen measurement
PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
Other Name: PSA levels

Other: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Other Name: questionnaire administration

Experimental: Men 18-39: Educational intervention
Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
Other: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Other Names:
  • PowerPoint Presentation
  • Intervention, Educational

Other: Pre-test administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Other Name: questionnaire administration

Other: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Other Name: Program Evaluation

Other: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Other Name: questionnaire administration




Primary Outcome Measures :
  1. Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening [ Time Frame: Up to 1 year ]
    Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.

  2. Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions [ Time Frame: Up to 1 year ]
    Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.


Secondary Outcome Measures :
  1. Proportion of participants who choose to enter the clinical trial [ Time Frame: Up to 1 year ]
  2. Proportion of participants who choose screening after educational intervention [ Time Frame: Up to 1 year ]
  3. 10-year expected mortality based on USCF 10-year Mortality Index for all participants [ Time Frame: Up to 1 year ]
  4. Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention [ Time Frame: Up to 1 year ]
  5. Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines [ Time Frame: Up to 1 year ]
  6. Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study [ Time Frame: Up to 1 year ]
  7. Proportion of participants with family history of prostate cancer [ Time Frame: Up to 1 year ]
  8. Proportion of participants referred to a primary care physician who did not previously have a primary care physician [ Time Frame: Up to 1 year ]
  9. Proportion of participants who asked the physician to make a decision for them in spite of educational intervention [ Time Frame: Up to 1 year ]
  10. Proportion of participants who expressed satisfied with this proposed informed consent and education model [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
  • Educational component: men over the age of 18
  • Screening component: men over age 40

Exclusion Criteria:

  • Known personal history of prostate cancer
  • Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy

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): NCT02419846


Locations
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United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Samir Abraksia, MD    216-491-6438    sabraksi@ccf.org   
Principal Investigator: Samir Abraksia         
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Samir Abraksia, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02419846     History of Changes
Other Study ID Numbers: CASE3815
NCI-2015-00478 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 3815 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
Informed Decision Making
Prostate
Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases