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

Cancer Clinical Trial

— eReach  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353973
• Other study ID #: UPCC 11919
• Secondary ID: IRB#833370
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Angela R Bradbury, MD
• Phone: 215 615 3341
• Email: Angela.Bradbury[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Disease Susceptibility

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	AstraZeneca, Basser Center for BRCA, Fox Chase Cancer Center, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge	Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).	Baseline - Within 7 days of Visit 2
Primary	Change in Anxiety	Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better).	Baseline - Within 7 days of Visit 2
Secondary	Change in Depression	Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better).	Baseline - Within 7 days of Visit 2
Secondary	Change in Cancer Specific Distress	Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better).	Baseline - Within 7 days of Visit 2
Secondary	Change in Uncertainty	Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better).	Within 7 days of Visit 2 - 6-Month Follow-Up
Secondary	Change in Health Behaviors	Change in treatment plan and communication of results - Yes/No	Within 7 days of Visit 2 - 6-Month Follow-Up
Secondary	Provider Time	Time (minutes) provider spends per study participant	Within 7 days of Standard of Care V1
Secondary	Provider Time	Time (minutes) provider spends per study participant	Within 7 days of Standard of Care V2
Secondary	Frequency of Uptake of Testing	Testing uptake per arm - Yes/No	Within 7 days of Visit 1