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Understanding of Genetics by Men at Risk for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus group analyses
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring Prostate Cancer, Genetic Literacy, Heath Communication, Focus Group Discussions, Prognostic Genomics Technology

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Localized prostate cancer (stage 1 and 2)
  • Age 40 and older
  • Male
  • Able and willing to provide informed consent
  • English-speaking
  • Willing to participate in the study

Exclusion Criteria:

  • Men with metastatic prostate cancer
  • Plan to move out of the area within the next 12 months
  • Severe persistent mental illness such as dementia

Sites / Locations

  • Mayo ClinicRecruiting
  • Mayo ClinicRecruiting
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.

Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching.

Arm Description

Focus group discussions about the PCGLA educational video post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.

Focus group discussions about the PCGLA educational plus nurse-navigated, tailored, prostate cancer education and communication coaching post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.

Outcomes

Primary Outcome Measures

Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Prostate Cancer Genetic Understanding
The Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video, which was developed for this research, will be used as the study educational intervention. Prostate Cancer Genetic understanding will be assess with an 18-item knowledge prostate cancer genetic survey. The items are True or False.
Focus Group Discussion
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Focus Group Discussion
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.

Secondary Outcome Measures

Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Demographic Characteristics
Patients will be asked ended-questions to assess (1) race, (2) age, (3) marital status, (4) employment status, (5) current and/or past prostate cancer diagnoses, (6) occupation, (7) level of education, and 8) income.

Full Information

First Posted
September 9, 2020
Last Updated
October 19, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04550845
Brief Title
Understanding of Genetics by Men at Risk for Prostate Cancer
Official Title
Understanding of Genetics by Men at Risk for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 27, 2027 (Anticipated)
Study Completion Date
September 27, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
With this greater certainty regarding prognosis, men with localized prostate cancer are now equipped with make better treatment planning decisions. This study is designed to investigate the understanding of prognostic genetic technology in African American and rural White men at risk for localized prostate cancer.
Detailed Description
Novel genomic technology, such as microarray analyses and next-generation sequencing, have improved the understanding of prostate cancer biology and prognosis. The National Comprehensive Cancer Network (NCCN), in 2016, recommended that patients and clinicians consider tissue-based genetic tests for localized prostate cancer. However, while much enthusiasm currently exits for the rapidly increasing field of genomic medicine, the use of multi-gene mRNA expression panels raises the potential for further divergence in prostate cancer treatment outcomes by race and low socioeconomic status. We know that health disparities persist in low income groups despite the existence of evidence-based guidelines and that adoption of state-of-the-art methods often lag behind in these groups. The goals of this study are to explore how men at risk for localized prostate cancer comprehend prognostic genetic technology, and examine how an educational video about genetics impacts patient-caregiver communication of prognostic genetic technology. The study rationale is that without direct attention to genomic comprehension, the enthusiasm that exists in the rapidly increasing field of prostate cancer genomic medicine may not translate into health benefits for men with localized prostate cancer. The central hypotheses are men with lower levels of education will demonstrate a severe lack of genomic comprehension of tissue-based genetic tests for localized prostate cancer; and tailored prostate cancer education will significantly improve communication in a low literacy population. The study approach is innovative because it applies a mixed-methods community-engagement research framework to explore how African American and rural White men at risk for localized prostate cancer, comprehend and interpret data generated from genetic technology. The proposed research is significant because of its potential to improve public health by improving the understanding of prognostic genetics in minority, low income, and rural populations, and engage and educate these diverse communities about genomics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Genetic Literacy, Heath Communication, Focus Group Discussions, Prognostic Genomics Technology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.
Arm Type
Experimental
Arm Description
Focus group discussions about the PCGLA educational video post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.
Arm Title
Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching.
Arm Type
Experimental
Arm Description
Focus group discussions about the PCGLA educational plus nurse-navigated, tailored, prostate cancer education and communication coaching post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.
Intervention Type
Behavioral
Intervention Name(s)
Focus group analyses
Intervention Description
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
Primary Outcome Measure Information:
Title
Estimate Genetic Literacy
Description
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Time Frame
Baseline
Title
Estimate Genetic Literacy
Description
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Time Frame
Pre-intervention
Title
Estimate Genetic Literacy
Description
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Time Frame
Immediately after the intervention
Title
Prostate Cancer Genetic Understanding
Description
The Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video, which was developed for this research, will be used as the study educational intervention. Prostate Cancer Genetic understanding will be assess with an 18-item knowledge prostate cancer genetic survey. The items are True or False.
Time Frame
Baseline
Title
Focus Group Discussion
Description
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Time Frame
Baseline
Title
Focus Group Discussion
Description
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Prostate Cancer Knowledge Scale
Description
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Time Frame
Baseline
Title
Prostate Cancer Knowledge Scale
Description
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Time Frame
Pre-intervention
Title
Prostate Cancer Knowledge Scale
Description
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Time Frame
Immediately after the intervention
Title
Demographic Characteristics
Description
Patients will be asked ended-questions to assess (1) race, (2) age, (3) marital status, (4) employment status, (5) current and/or past prostate cancer diagnoses, (6) occupation, (7) level of education, and 8) income.
Time Frame
Baseline

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African-American or White men Living in a rural or urban areas Age 40 to 95 years old Able and willing to provide informed consent English-speaking Willing to participate in the study. This study will use the United States Department of Agriculture Office of Rural Development's definition of rural, which is as a city or town that has a population less than 50,000 inhabitants to define rural. This study will use the United States Census Bureau's definition of urban, which is a city or town that has a population greater than 50,000 inhabitants to define urban. Exclusion Criteria: Women will be excluded from participating in this study. However, women will be recruited to serve on an advisory panel to review the video-based educational tool for the comprehension of genomic terminology for prognostic genetic testing in patients with localized prostate cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewan K Cobran, PhD
Phone
480-301-6392
Email
cobran.ewan@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewan K Cobran, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ewan K Cobran, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Understanding of Genetics by Men at Risk for Prostate Cancer

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