Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2025-02-13

Brief Summary

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This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.

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Detailed Description

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Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.

This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ARM A

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Group Type EXPERIMENTAL

Standard of Care

Intervention Type OTHER

Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)

ARM B

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Group Type EXPERIMENTAL

Standard of Care

Intervention Type OTHER

Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)

Post-Test Intervention

Intervention Type OTHER

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

ARM C

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.

Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Group Type EXPERIMENTAL

Pre-Test Intervention

Intervention Type OTHER

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Standard of Care

Intervention Type OTHER

Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)

ARM D

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.

Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Group Type EXPERIMENTAL

Pre-Test Intervention

Intervention Type OTHER

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Post-Test Intervention

Intervention Type OTHER

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Interventions

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Pre-Test Intervention

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Intervention Type OTHER

Standard of Care

Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)

Intervention Type OTHER

Post-Test Intervention

Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Speak and understand English
* Male or Female
* A personal history of one or more of the following:

* metastatic breast cancer
* advanced ovarian cancer (Stage III-IV)
* metastatic pancreatic cancer
* metastatic prostate cancer
* Naive to previous cancer germline genetic testing

Exclusion Criteria

* Communication difficulties such as:

* Uncorrected or uncompensated hearing and/or vision impairment
* Uncorrected or uncompensated speech defects
* Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes