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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Cancer

Treatments: Other: Pre-Test Intervention; Other: Post-Test Intervention; Other: Standard of Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04353973

IRB#833370 (Other Identifier)

UPCC 11919

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 4 patient groups

ARM A

Experimental group

Description:

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).

Treatment:

Other: Standard of Care

ARM B

Experimental group

Description:

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.

Treatment:

Other: Standard of Care

Other: Post-Test Intervention

ARM C

Experimental group

Description:

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).

Treatment:

Other: Standard of Care

Other: Pre-Test Intervention

ARM D

Experimental group

Description:

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.

Treatment:

Other: Post-Test Intervention

Other: Pre-Test Intervention