Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Condition: Genetic Predisposition
MeSH terms: Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      This 2-arm prospective, randomized, controlled clinical trial compared outcomes of telephone
      genetic counseling (intervention) versus in-person genetic counseling (control) in an
      underserved, multilingual patient population referred for cancer genetic counseling at two
      North Texas safety-net hospitals.

      The main question[s] it aims to answer are:

        -  Is telephone genetic counseling equal to in-person genetic counseling in the patient
           reported outcomes? Cancer genetics knowledge, attitude towards GT, and informed choice
           as well as GC-specific empowerment.

        -  Is telephone genetic counseling-based clinical outcomes the same as in-person genetic
           counseling for visit completion and testing rates? Participants will be randomized to
           either in-person or telephone genetic counseling arm and complete standard of care
           genetic counseling visit process where testing is offered. Both arms will complete a
           series of surveys to assess the outcomes of interest.
    

Detailed description: 
      The overarching goal of this pilot prospective randomized controlled study is to compare
      patient-reported and clinical operations outcomes between in-person genetic counseling (IPGC
      - control) and telephone-based genetic counseling (TGC - intervention) in an indigent English
      or Spanish-speaking population seeking genetic counseling for hereditary cancer syndromes to
      create a framework for effective and efficient genetic service delivery in these populations
      nationally. General genetic education and principles will be conveyed through a standard
      genetic counseling session including a pre-test education video in both the TGC and IPGC
      arms. Our primary project objectives are to compare the following outcomes between the IPGC
      and TGC study arms. Aim 1: Patient reported outcomes - A. Patient satisfaction with genetic
      counseling visit; B. Knowledge of basic principles of cancer genetics and implications of
      genetic testing for personal healthcare and relatives. Secondary objectives for this aim are:
      1. Patient ability to make informed choice; and 2. Genetic counseling-specific empowerment
      outcomes. Aim 2: Clinical outcomes - visit completion rate; Secondary objectives are: 1.
      Genetic testing completion rate; and 2. Genetic testing cancelation/failure rate. We
      hypothesize that patients in the TGC arm will not have significant differences in knowledge,
      satisfaction, informed choice or genetic counseling-specific empowerment compared to the IPGC
      arm. We also expect significantly increased visit completion rate and lower test completion
      rate in the TGC arm compared to the IPGC arm, but no significant difference in sample failure
      rate.
    

Intervention name(s): Telephone genetic counseling
Intervention type(s): Other
Intervention description(s): genetic counseling service delivered audio-only
Other intervention name(s): service delivery type
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pilot prospective controlled 2-arm randomized trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: genetic counseling service delivery