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

NCT02419846 | Terminated DMC

• 1 other identifier: CASE3815
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Keywords

Informed Decision Making; Prostate; Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening

  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%.

  Up to 1 year

• 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

  Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.

  Up to 1 year

Secondary Outcomes (10)

• Proportion of participants who choose to enter the clinical trial

  Up to 1 year

• Proportion of participants who choose screening after educational intervention

  Up to 1 year

• 10-year expected mortality based on USCF 10-year Mortality Index for all participants

  Up to 1 year

• Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention

  Up to 1 year

• Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines

  Up to 1 year

Study Arms (2)

Men over 40: Screening with intervention

EXPERIMENTAL

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; Procedure: digital rectal examination; Other: Pre-test administration; Other: Survey Administration; Other: Prostate-specific antigen measurement; Other: Post test administration

Men 18-39: Educational intervention

EXPERIMENTAL

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; Other: Pre-test administration; Other: Survey Administration; Other: Post test administration

Interventions

Educational Intervention OTHER

Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences

Also known as: PowerPoint Presentation, Intervention, Educational

Men 18-39: Educational intervention; Men over 40: Screening with intervention

digital rectal examination PROCEDURE

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

Also known as: DRE

Men over 40: Screening with intervention

Pre-test administration OTHER

15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers

Also known as: questionnaire administration

Men 18-39: Educational intervention; Men over 40: Screening with intervention

Survey Administration OTHER

Survey will be administered at the end of the program for participants to assess their experience

Also known as: Program Evaluation

Men 18-39: Educational intervention; Men over 40: Screening with intervention

Prostate-specific antigen measurement OTHER

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

Also known as: PSA levels

Men over 40: Screening with intervention

Post test administration OTHER

Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding

Also known as: questionnaire administration

Men 18-39: Educational intervention; Men over 40: Screening with intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Early Intervention, Educational; Methods; Program Evaluation; Prostate-Specific Antigen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques; Evaluation Studies as Topic; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation; Kallikreins; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Prostatic Secretory Proteins; Seminal Plasma Proteins; Seminal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Biomarkers, Tumor; Biomarkers

Study Officials

• Samir Abraksia, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: July 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)