Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
21 juli 2022 uppdaterad av: Case Comprehensive Cancer Center
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
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
319
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44106-5065
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andra namn:
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
Andra namn:
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
Andra namn:
Survey will be administered at the end of the program for participants to assess their experience
Andra namn:
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
Andra namn:
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andra namn:
|
|
Experimentell: 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.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andra namn:
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
Andra namn:
Survey will be administered at the end of the program for participants to assess their experience
Andra namn:
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Tidsram: 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%.
|
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
Tidsram: 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.
|
Up to 1 year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of participants who choose to enter the clinical trial
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants who choose screening after educational intervention
Tidsram: Up to 1 year
|
Up to 1 year
|
|
10-year expected mortality based on USCF 10-year Mortality Index for all participants
Tidsram: Up to 1 year
|
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
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants with family history of prostate cancer
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants referred to a primary care physician who did not previously have a primary care physician
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
Tidsram: Up to 1 year
|
Up to 1 year
|
|
Proportion of participants who expressed satisfied with this proposed informed consent and education model
Tidsram: Up to 1 year
|
Up to 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Samir Abraksia, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2015
Primärt slutförande (Faktisk)
1 oktober 2021
Avslutad studie (Faktisk)
1 juli 2022
Studieregistreringsdatum
Först inskickad
14 april 2015
Först inskickad som uppfyllde QC-kriterierna
14 april 2015
Första postat (Uppskatta)
17 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juli 2022
Senast verifierad
1 juli 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CASE3815
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .