Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.

Focus group analyses

Ewan K Cobran, PhD

Clinical Trials Referral Office

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.

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.

Understanding of Genetics by Men at Risk for Prostate Cancer

The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.

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.

A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.

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.

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.

National Cancer Institute (NCI)

Mayo Clinic

Senior Associate Consultant, Principal Investigator

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Heart and Blood Diseases

Rare Diseases

Diabetes Mellitus

Stroke

Heart Diseases

Chronic Graft Versus Host Disease

Relational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History).

Online family health history collection tool (MFHP: My Family Health Portrait).

VICKY

MFHP

Catharine Wang

A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.

Using Virtual Counselors to Overcome Genetic Literacy Barriers

Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY

Sensitivity will be calculated using an interview with a genetic counselor as the gold standard. Sensitivity will be defined as the health conditions identified by the family health history tool (VICKY or MFHP) that were also identified by the genetic counselor (true positive) divided by the health conditions not captured by the tool but captured by the genetic counselor (false negatives) plus the true positives.

Accuracy of family members identified will be defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor.

Communication of family health history with family members and health care providers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Understanding of Genetics by Men at Risk for Prostate Cancer	NCT04550845	Prostate Cancer	Focus group ana...	40 Years - 95 Years	Mayo Clinic
Using Virtual Counselors to Overcome Genetic Literacy Barriers	NCT02344433	Heart Disease Stroke Diabetes Cancer	VICKY MFHP	21 Years -	Boston University
Using Virtual Counselors to Overcome Genetic Literacy Barriers	NCT02344433	Heart Disease Stroke Diabetes Cancer	VICKY MFHP	21 Years -	Boston University

Spots Global Cancer Trial Database for genetic literacy