Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Nurse-navigated coaching for prostate cancer?
Research shows that nurse-led decision coaching can help patients make informed decisions about their health, as seen in studies with women at risk for breast and ovarian cancer. This suggests that similar nurse-navigated coaching could be beneficial for prostate cancer patients in understanding genetic risks and making treatment decisions.
12345How does the treatment in the Genetic Education for Prostate Cancer trial differ from other treatments for prostate cancer?
The treatment in this trial focuses on genetic education, which is unique because it aims to increase understanding of hereditary prostate cancer, particularly among high-risk groups, rather than directly treating the cancer itself. This approach is different from standard treatments that typically involve medication or surgery.
26789Eligibility Criteria
This study is for English-speaking African American and rural White men aged 40 or older who have early-stage (stage 1 or 2) prostate cancer. Participants must be willing to provide informed consent and participate in the study. Men with advanced prostate cancer, plans to move soon, or severe mental illness like dementia cannot join.Inclusion Criteria
English-speaking
My prostate cancer is in the early stages (1 or 2).
I am willing to participate in the study.
+2 more
Exclusion Criteria
You have a serious and ongoing mental illness like dementia.
I am a man with prostate cancer that has spread.
Plan to move out of the area within the next 12 months
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline assessments including demographic characteristics and prostate cancer genetic understanding
1 week
1 visit (in-person)
Intervention
Participants view the PCGLA educational video and engage in focus group discussions
1 week
1 visit (in-person)
Follow-up
Participants are monitored for genetic literacy and understanding immediately after the intervention
Immediately after intervention
Participant Groups
The trial is focused on understanding how these men perceive genetic technology that helps predict the outcome of localized prostate cancer. It involves participating in focus group discussions to gather insights into their decision-making processes regarding treatment planning.
2Treatment groups
Experimental Treatment
Group I: Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.Experimental Treatment1 Intervention
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.
Group II: Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching.Experimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicJacksonville, FL
Mayo ClinicPhoenix, AZ
University of GeorgiaAthens, GA
Mayo Clinic in FloridaJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
University of GeorgiaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study. [2022]Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training.
Effect of a health literacy training program for surgical oncologists and specialized nurses on disparities in referral to breast cancer genetic testing. [2021]There is an underuse of genetic testing in breast cancer patients with a lower level of education, limited health literacy or a migrant background. We aimed to study the effect of a health literacy training program for surgical oncologists and specialized nurses on disparities in referral to genetic testing.
A genetics perspective on prostate cancer. [2010]Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths among American men. In a small percentage of men, prostate cancer occurs as a result of inheriting a mutation in a major gene predisposing to this disease. The genome-wide search for prostate cancer susceptibility genes holds the promise of making genetic testing for prostate cancer risk available in the future and for ultimately developing better tools for disease prevention, diagnosis, and treatment. Nursing practice roles are increasingly affected by the translation of rapidly expanding genetic knowledge into the patient care arena. The current advances in the genetic basis of prostate cancer, including screening and management aspects and risk assessment considerations for urologic nursing practice, are addressed.
Oncology Nurses' Knowledge of Pharmacogenomics Before and After Implementation of an Education Module. [2019]To assess the efficacy of an interactive continuing education module in improving knowledge of pharmacogenomics in oncology nursing practice.
Oncology nurses' knowledge, practice, and educational needs regarding cancer genetics. [2019]This study evaluated oncology nurses' knowledge of cancer genetics and related topics, and identified current practice patterns and perceived educational needs in this area. A 54-item study questionnaire was mailed to a random sample of 1,200 Oncology Nursing Society (ONS) members and 75 members of the ONS-Cancer Genetics Special Interest Group; 656 (51%) of those eligible responded. After exclusions, we analyzed 573 responses. Most respondents were Caucasian, female, and worked in hospital or outpatient settings. Half were staff nurses and 8% specialized in cancer genetics. Respondents with higher levels of nursing education or with continuing education in cancer genetics, who worked in positions other than staff nurses, and whose primary practice area was cancer genetics had significantly higher mean scores overall on questions measuring knowledge of cancer genetics and related areas. Higher perceived educational needs to improve knowledge or practice related to cancer genetics at basic, intermediate or advanced levels were associated with all or some of the following variables: lower education; hospital/ outpatient or managed care/private practice settings; lack of continuing education in cancer genetics, and positions other than advanced practice nurses. Although nearly half of the respondents had received patient inquiries regarding cancer genetics, only 35% were aware of referral resources and 26% had made such referrals. These findings may be used to develop targeted educational approaches that prepare oncology nurses to incorporate cancer genetics into any level of practice.
Knowledge of hereditary prostate cancer among high-risk African American men. [2022]To measure knowledge of hereditary prostate cancer in a group of high-risk African American men.
Pilot study of an online training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing BRCA1/2 genetic testing with breast and ovarian cancer patients. [2022]The increasing use of genetic testing for BRCA1/2 and other pathogenic variants in the management of women with breast and ovarian cancer necessitates increased genetic literacy in oncology healthcare professionals. This pilot study aimed to evaluate an online training program to increase genetic literacy and communication skills in Australian oncology healthcare professionals tasked with discussing and coordinating mainstream genetic testing with breast and ovarian cancer patients. A training website with embedded videos was developed. This study assesses the website's acceptability and user-friendliness; suggestions for improvement were also elicited. Oncology healthcare professionals were recruited through relevant professional organisations, invited to the study by email, asked to work through the website and then complete an online questionnaire. Thirty-two oncology healthcare professionals completed the questionnaire after viewing the website. Nearly all participants were satisfied with the information contained in the program (very satisfied: n = 14/32, 44%, satisfied: n = 17/32, 53%, neither satisfied nor dissatisfied: n = 1/32, 3%) and reported that they had gained new skills (n = 29/32, 91%) and had increased confidence (n = 29/31, 94%) in communicating with breast and ovarian cancer patients about genetic testing. More than 93% (28/30) of participants endorsed the online program as clearly presented, informative, relevant and useful. This pilot study demonstrated high feasibility and acceptability of the training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing genetic testing with breast and ovarian cancer patients. Further evidence from a randomised trial is needed to evaluate effects on changing clinical practice, improving patient outcomes, and cost-effectiveness.
Experience with a nurse-driven genetic counseling pathway of Italian women with uninformative BRCA test result. [2023]Several models of genetic counseling have been proposed to tackle the increasing volume of individuals requiring access to BRCA testing. Few data are available on patient experience and retention of information with nurse-driven genetic counseling. We evaluated the experience and retention of information in women with an uninformative BRCA test result and who were not considered at high risk due to their personal/family history of cancer who underwent geneticist-supervised nurse-driven genetic counseling and who received their test result by phone. Women who received an uninformative BRCA test result between May 2017 and September 2019 were administered a questionnaire exploring experience with genetic counseling and retention of information provided. Of 366 eligible women, 299 (273 breast cancer patients and 26 women without breast cancer) completed the interview. Overall, 280 women (93.6%) positively valued their experience with genetic counseling and 287 (96.0%) considered it helpful with 57.5% of them feeling reassured for themselves and their family. Information on the clinical implications of the test result was correctly retained and women acted accordingly. Overall, 252 women (87.8%) accurately reported their test result as normal/negative. Only 67 (22.4%) recognized that despite a normal BRCA test result, a low probability of a hereditary syndrome remains. Most women showed a poor ability to estimate cancer risk in BRCA mutation carriers and in the general population. Geneticist-supervised nurse-driven genetic counseling process for women with uninformative BRCA test result is associated with a positive patient experience and an adequate retention of information concerning the management of their personal and familial cancer risk. The design and implementation of nurse-driven genetic counseling models may contribute to efficient and timely access to BRCA genetic testing.
Patient and Health Care Provider Needs and Preferences in Understanding Pharmacogenomic and Genomic Testing: A Meta-Data Analysis. [2020]Tests that feature genomic indicators can now be used to guide the pharmacological treatment of patients. To better identify the needs and preferences of patients and health care providers in facilitating their understanding of information related to such pharmacogenomic tests (PGx), a review of literature on knowledge translation and health literacy in the context of testing was conducted. Using a grounded theory-based approach, a comparative analysis of data from 36 studies meeting the criteria for the meta-data analysis has revealed the recurrence of three principal themes: (a) knowledge and understanding of genetics and pharmacogenomics; (b) experiences with genetic, genomic, or PGx testing (decision about the test, information delivery, and understanding of test results); and (c) educational/informational resources. This synthesis sheds light on each theme from the standpoint of both patients and health care providers and suggests avenues in which to direct efforts to support the introduction of pharmacogenomic tests in current practice.