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

NCT04353973 | Completed DMC

• 2 other identifiers: UPCC 11919IRB#833370
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Change in Knowledge

  Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).

  Baseline - Within 7 days of Visit 2

• 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 Outcomes (7)

• Change in Depression

  Baseline - Within 7 days of Visit 2

• Change in Cancer Specific Distress

  Baseline - Within 7 days of Visit 2

• Change in Uncertainty

  Within 7 days of Visit 2 - 6-Month Follow-Up

• Change in Health Behaviors

  Within 7 days of Visit 2 - 6-Month Follow-Up

• Provider Time

  Within 7 days of Standard of Care V1

Study Arms (4)

ARM A

EXPERIMENTAL

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

ARM B

EXPERIMENTAL

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; Other: Post-Test Intervention

ARM C

EXPERIMENTAL

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; Other: Standard of Care

ARM D

EXPERIMENTAL

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; Other: Post-Test Intervention

Interventions

Pre-Test Intervention OTHER

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.

ARM C; ARM D

Standard of Care OTHER

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

ARM A; ARM B; ARM C

Post-Test Intervention OTHER

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.

ARM B; ARM D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• AstraZeneca: collaborator
• Fox Chase Cancer Center: collaborator
• Basser Center for BRCA: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Lee KT, McLeod B, Egleston B, Brown S, Howe S, Fetzer D, Gutstein L, Cacioppo C, Clark D, Domchek SM, Ebrahimzadeh J, Falcone D, Ofidis D, Griffin H, Mim R, Hernandez S, Fleisher L, Karpink K, Selmani E, Tahsin A, Wagner L, Weinberg M, Yi-Wen K, Wood E, Bradbury AR. An eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Patients With Metastatic Cancers: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Aug 25;14:e72515. doi: 10.2196/72515.

  PMID: 40853717 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 21, 2020
• Study Start: August 17, 2020
• Primary Completion: August 15, 2024
• Study Completion: February 13, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)