Clinical trial NCT04353973: Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients
Official title: A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Fox Chase Cancer Center
name: Basser Center for BRCA
name: Merck Sharp & Dohme LLC
First posted: 2020-04-21
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knowledge
timeFrame: Baseline - Within 7 days of Visit 2
measure: Change in Anxiety
timeFrame: Baseline - Within 7 days of Visit 2
Secondary outcomes:
measure: Change in Depression
timeFrame: Baseline - Within 7 days of Visit 2
measure: Change in Cancer Specific Distress
timeFrame: Baseline - Within 7 days of Visit 2
measure: Change in Uncertainty
timeFrame: Within 7 days of Visit 2 - 6-Month Follow-Up
measure: Change in Health Behaviors
timeFrame: Within 7 days of Visit 2 - 6-Month Follow-Up
measure: Provider Time
timeFrame: Within 7 days of Standard of Care V1
measure: Provider Time
timeFrame: Within 7 days of Standard of Care V2
measure: Frequency of Uptake of Testing
timeFrame: Within 7 days of Visit 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
References: