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

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Other: Standard of Care; Other: Pre-Test Intervention; Other: Post-Test Intervention

• Registration Number: NCT04353973
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-08-17
• Primary Completion: 2024-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM B	Standard of Care	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.
ARM B	Post-Test Intervention	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.
ARM C	Pre-Test Intervention	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).
ARM A	Standard of Care	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).
ARM C	Standard of Care	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).
ARM D	Pre-Test Intervention	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.
ARM D	Post-Test Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Knowledge	Baseline - Within 7 days of Visit 2	Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).
Change in Anxiety	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

Name	Time	Method
Change in Cancer Specific Distress	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).
Change in Depression	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).
Change in Health Behaviors	Within 7 days of Visit 2 - 6-Month Follow-Up	Change in treatment plan and communication of results - Yes/No
Provider Time	Within 7 days of Standard of Care V2	Time (minutes) provider spends per study participant
Change in Uncertainty	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).
Frequency of Uptake of Testing	Within 7 days of Visit 1	Testing uptake per arm - Yes/No

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States