Prostate Cancer Genetic Literacy and Patient-Caregiver Communication

• ClinicalTrials.gov Identifier: NCT04550845
• Recruitment Status: Not yet recruiting
• First Posted: September 16, 2020
• Last Update Posted: July 19, 2021
• Sponsor: University of Georgia
• Information provided by (Responsible Party): Ewan K. Cobran, University of Georgia

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 and patient-caregiver communication in African American and rural White men with localized prostate cancer.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Nurse-navigated coaching	Not Applicable

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 (1) explore how men with localized prostate cancer and their caregivers comprehend prognostic genetic technology, and (2) 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 (1) men and caregivers with lower levels of education will demonstrate a severe lack of genomic comprehension of tissue-based genetic tests for localized prostate cancer; and (2) tailored prostate cancer education, communication coaching, and a genomic literacy educational video will significantly improve patient-caregiver 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 with 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 (1) improving the understanding of prognostic genetics in minority, low income, and rural populations, and (2) engage and educate these diverse communities about genomics.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Genetic Literacy and Patient-Caregiver Communication of Prognostic Genetic Technology for Localized Prostate Cancer
• Estimated Study Start Date: September 27, 2021
• Estimated Primary Completion Date: February 1, 2025
• Estimated Study Completion Date: December 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Specific Aim 1; In specific aim 1, twelve focus group interviews (AA and rural White men with localized prostate cancer and caregivers, N = 50 dyads or N = 100 participants) will be conducted to explore comprehension of prognostic genomics as well as facilitators and barriers to genomic health literacy and to assess the acceptability and value of the revised PCLA education video.	Behavioral: Nurse-navigated coaching; The nurse-navigated coaching intervention will be based on the Patient Navigation Research Program (PNRP), sponsored by the National Cancer Institute (NCI) Center to Reduce Cancer Health Disparities. The goal of patient navigation is to facilitate timely access to quality cancer care that meets cultural needs and standards of care for all patients. Examples of navigation services includes identifying and scheduling appointments with culturally sensitive providers, addressing health literacy, coordinating care among providers, ensuring coordination of services among medical personnel, and providing other services to overcome access barriers encountered during the cancer care process.
Experimental: Specific Aim 2; In specific aim 2, participants will be randomized into intervention versus control group. Twenty focus groups (AA and rural White men with localized prostate cancer and caregivers, N = 80 dyads or N = 160 participants) will be conducted to culturally conceptualize the study intervention and to provide qualitative contextual evaluation. The design for this aim is a randomized controlled, parallel group, repeated measures, non-blinded trial, with a nurse-delivered tailored prostate cancer education, communication coaching, and the prognostic genomics revised Prostate Cancer Literacy Video compared to the prognostic genomics revised Prostate Cancer Literacy Video.	Behavioral: Nurse-navigated coaching; The nurse-navigated coaching intervention will be based on the Patient Navigation Research Program (PNRP), sponsored by the National Cancer Institute (NCI) Center to Reduce Cancer Health Disparities. The goal of patient navigation is to facilitate timely access to quality cancer care that meets cultural needs and standards of care for all patients. Examples of navigation services includes identifying and scheduling appointments with culturally sensitive providers, addressing health literacy, coordinating care among providers, ensuring coordination of services among medical personnel, and providing other services to overcome access barriers encountered during the cancer care process.

Outcome Measures

Primary Outcome Measures :

1. Genetic Literacy [ Time Frame: Baseline, Change from Baseline Genetic Literacy at 4 weeks weeks post-entry, and Change from Baseline Genetic Literacy at 3 months post-entry. ]
   The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used. To score, each correctly pronounced word is marked "+", each incorrectly pronounced word is marked with a check, and each skipped word is marked "_". Raw scores are generated by calculating the number of correctly pronounced words. Scoring categories: Sum score 0-21 = estimated literacy level less than 4th grade, 22-50 4th through 6th grade, 51-60 7th to 8th grade, and 61-63 high school.

Secondary Outcome Measures :

1. Patient Caregiver Communication [ Time Frame: Baseline, Change from Baseline Patient Caregiver Communication at 4 weeks weeks post-entry, and Change from Baseline Patient Caregiver Communication at 3 months post-entry. ]
   The 23-item Lewis Mutuality and Interpersonal Sensitivity Scale measures patient caregiver communication about prognostic genetics (i.e, "We spend a lot of time talking about prostate cancer genetics"; and "We approach prostate cancer genetics with the same thoughts and feelings"). A score of 1 to 5 is calculated by summing ratings across all items and dividing by 23. Higher scores indicate more perceived open communication between the patient and caregiver about cancer.
2. Subjective Numeracy Scale [ Time Frame: Baseline, Change from Baseline Subjective Numeracy at 4 weeks weeks post-entry, and Change from Baseline Subjective Numeracy at 3 months post-entry. ]
   The Subjective Numeracy Scale is a self-report measure of perceived ability to perform various mathematical tasks and preference for the use of numerical versus prose information. The 8-item scale contains no mathematics questions and has no correct or incorrect answers. Instead, it consists of 4 questions asking respondents to assess their numerical ability in different contexts and 4 questions asking them to state their preferences for the presentation of numerical and probabilistic information.The 8-item scale contains no mathematics questions and has no correct or incorrect answers. Instead, it consists of 4 questions asking respondents to assess their numerical ability in different contexts and 4 questions asking them to state their preferences for the presentation of numerical and probabilistic information. All questions use 6-point Likert-type scales with endpoints as marked. Response values increase left to right (1-6).
3. Prostate Cancer Knowledge Scale [ Time Frame: Baseline, Change from Baseline Prostate Cancer Knowledge at 4 weeks weeks post-entry, and Change from Baseline Prostate Cancer Knowledge at 3 months post-entry. ]
   The Prostate Cancer Knowledge Scale s 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Ewan K Cobran, PhD; (706) 542-5327; ecobran@uga.edu

Contact: Kim Schmitz, MS; 706-713-2722; schmitzk@uga.edu

Locations

United States, Georgia

University of Georgia

Athens, Georgia, United States, 30602

Contact: Ewan K Cobran, PhD 706-542-5327 ecobran@uga.edu

Principal Investigator: Ewan K Cobran, PhD

Sponsors and Collaborators

University of Georgia

Investigators

• Principal Investigator: Ewan K Cobran, PhD; University of Georgia

More Information

• Responsible Party: Ewan K. Cobran, Assistant Professor, College of Pharmacy, University of Georgia
• ClinicalTrials.gov Identifier: NCT04550845
• Other Study ID Numbers: PROJECT00002709
• First Posted: September 16, 2020
• Last Update Posted: July 19, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ewan K. Cobran, University of Georgia:

Prostate Cancer; Genetic Literacy; Heath Communication; Patient-Caregiver Dyads; Focus Group Discussions; Prognostic Genomics Technology

Additional relevant MeSH terms:

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