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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    560
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 28 October 2021
breast cancer
metastasis
advanced cancer
primary cancer
ovarian cancer
stage iv breast cancer
genetic testing
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition cancers, malignant tumor, malignancy, Cancer, Cancer (Pediatric), malignant tumors, primary cancer, Cancer/Tumors, malignancies, Ewing's Family Tumors, primary malignant neoplasm, Neoplasms
Treatment Standard of Care, Pre-Test Intervention, Post-Test Intervention
Clinical Study IdentifierNCT04353973
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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