Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThomas Jefferson University

About this trial

This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide signed and dated informed consent form

English speaking only

Willing to comply with all study procedures and be available for the duration of the study

Any individual >= 18 years old

Disqualifiers

Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded

Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient Navigation

    Behavioral

    Receive peer navigation services

  • Genetic Counseling

    Other intervention

    Receive genetic counseling

  • Survey Administration

    Other intervention

    Ancillary studies

  • Best Practice

    Other intervention

    Receive standard care

  • Genetic Counseling

    Other intervention

    Receive genetic counseling

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm I (peer navigation)Experimental treatment 3 interventions
Group B: Arm II (best practice)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Frequency of pretest genetic counseling engagement

Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.

Time frame
Up to 4 years

Secondary outcomes

1

Mean changes in decisional conflict for genetic testing

Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.

Time frame
Up to 4 years
2

Mean changes in knowledge of cancer genetics

Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.

Time frame
Up to 4 years

Other outcomes

1

Healthcare system distrust

Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.

Time frame
Up to 4 years
2

Satisfaction with the genetic evaluation process

Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.

Time frame
Up to 4 years

Sponsors and contacts

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