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

• ClinicalTrials.gov Identifier: NCT04353973
• Recruitment Status: Recruiting
• First Posted: April 21, 2020
• Last Update Posted: October 20, 2021
• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: AstraZeneca; Fox Chase Cancer Center; Basser Center for BRCA; Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Abramson Cancer Center of the University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Other: Pre-Test Intervention; Other: Standard of Care; Other: Post-Test Intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: August 17, 2020
• Estimated Primary Completion Date: January 1, 2023
• Estimated Study Completion Date: January 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
Experimental: 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.	Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing); 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.
Experimental: 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).	Other: 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.; Other: Standard of Care; Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
Experimental: 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.	Other: 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.; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Knowledge [ Time Frame: Baseline - Within 7 days of Visit 2 ]
   Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).
2. Change in Anxiety [ Time Frame: Baseline - Within 7 days of Visit 2 ]
   Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better).

Secondary Outcome Measures :

1. Change in Depression [ Time Frame: Baseline - Within 7 days of Visit 2 ]
   Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better).
2. Change in Cancer Specific Distress [ Time Frame: Baseline - Within 7 days of Visit 2 ]
   Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better).
3. Change in Uncertainty [ Time Frame: Within 7 days of Visit 2 - 6-Month Follow-Up ]
   Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better).
4. Change in Health Behaviors [ Time Frame: Within 7 days of Visit 2 - 6-Month Follow-Up ]
   Change in treatment plan and communication of results - Yes/No
5. Provider Time [ Time Frame: Within 7 days of Standard of Care V1 ]
   Time (minutes) provider spends per study participant
6. Provider Time [ Time Frame: Within 7 days of Standard of Care V2 ]
   Time (minutes) provider spends per study participant
7. Frequency of Uptake of Testing [ Time Frame: Within 7 days of Visit 1 ]
   Testing uptake per arm - Yes/No

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Angela R Bradbury, MD; 215 615 3341; Angela.Bradbury@pennmedicine.upenn.edu

Contact: Dominique Fetzer, BA; 215 662 2753; Dominique.Fetzer@pennmedicine.upenn.edu

Locations

United States, Pennsylvania

Abramson Cancer Center at University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Angela Bradbury, MD Angela.Bradbury@uphs.upenn.edu

Principal Investigator: Angela Bradbury, MD

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

AstraZeneca

Fox Chase Cancer Center

Basser Center for BRCA

Merck Sharp & Dohme LLC

More Information

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04353973
• Other Study ID Numbers: UPCC 11919; IRB#833370 ( Other Identifier: University of Pennsylvania IRB )
• First Posted: April 21, 2020
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease Susceptibility; Disease Attributes; Pathologic Processes