Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital Patients

Specific Aims.

The specific aims of this mixed methods study are:

Aim 1. Compare the effectiveness of 3 modes of genetic counseling in a diverse sample of
patients at high risk for HBOC in 3 public hospitals. Conduct a multicenter partially
randomized preference noninferiority trial with high-risk patients assigned by (a)
randomization to three counseling modes: in-person, phone, video conference; or (b) patients´
preference. Utilize validated measures of study outcomes adapted as needed for literacy and
language. Recognizing that some potential participants may have a strong preference for one
counseling mode, after explaining the study design and obtaining informed consent,
participants will be asked if they have such a preference. Those who do will be offered that
mode, and those who do not will be randomized. Randomization will be stratified according to
hospital and personal history of breast cancer in order to ensure that there is no imbalance
in important factors that may be associated with outcome.

Aim 2. Explore inductively and qualitatively variation in patients' genetic counseling
experiences and understandings, genetic counselor satisfaction and perceptions, counseling
session similarities and differences, and implications of organizational context across three
modes of genetic counseling.

Aim 3 employs inductive, qualitative methods to explore in depth the cases of 30 patients
using their pre- and post-counseling survey responses, audio tapes of their counseling
session, and in-depth interviews to explore questions common to all respondents and those
specific to what was learned about the individual from the other data sources. In-depth
interviews will also be conducted with genetic counselors.

Study Design:

Using mixed methods, investigators will conduct a multicenter partially randomized preference
noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients
assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a)
in-person; (b) phone; or (c) video conference. A total of 600 patients will complete
counseling and 540 will complete the final survey. Baseline and post-counseling surveys will
use validated measures (adapted for literacy and language) of study outcomes. All counseling
sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content
and to identify 30 participants for in-depth interviews and analysis triangulating all forms
of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the
strengths and limitations of each counseling mode.

Investigators' mixed methods combine a multicenter partially randomized preference
noninferiority trial with inductive methods that embed this research in the real world of
public health system patients. This is practice-based research, designed to emphasize
external validity, (relevance and generalizability that enhance translation into actual use),
as well as internal validity. The purpose of a non-inferiority trial is to compare an
intervention to an active control or standard treatment when the intervention is not expected
to have superior efficacy, but to have other benefits, e.g., greater convenience or fewer
side effects. In the case of genetic counseling, in- person counseling is the standard of
care, with well-documented efficacy.4 Since video and telephone counseling do not offer a
more personalized approach or more pertinent content than in-person counseling, it seems
unlikely that either mode would produce superior psychosocial outcomes or greater knowledge
gains; similarly, investigators do not expect telephone counseling to be more efficacious
than video counseling.

The gold standard for assessing the effectiveness of interventions is the randomized clinical
trial; yet patients who have a strong preference for one of the intervention conditions may
decline to participate, which is a threat to external validity, or (if randomized)
participate half-heartedly or drop out, threatening internal validity. Investigators will
address this issue with a partially randomized preference trial in which patients with a
strong preference are assigned to their preferred treatment (i.e., intervention condition)
and those without a strong preference are randomized. This study design enables comparison of
treatment outcomes among patients who receive their preferred treatment (the desired real
world situation) and ascertainment of the effects of preference—as well as the evaluation of
treatment outcomes in a randomized trial. However, comparisons involving preference
participants are subject to confounding, since patients who prefer a particular treatment may
differ in ways that affect outcome. In analyses involving preference participants it is
possible to reduce confounding substantially using covariate adjustment. Nevertheless,
because residual confounding may be present, preference participant outcomes should be
considered observational data.

Investigators will blend qualitative and quantitative, deductive and inductive methods using
varied forms of data from in-depth interviews, surveys, and audio taped observations. This
will allow us to address our central question from different perspectives triangulated in the
analysis for a rich understanding of patient-counselor- institution relationships most of
which are too complex to describe using one dimension alone (e.g., cognitive understanding
captured in surveys). While the randomized trial is the gold standard for comparative
effectiveness, it cannot answer questions such as what it is about the counseling interaction
that was reassuring or anxiety-provoking to a patient? what techniques enabled a patient to
recall important points? or what about the conversation precluded such recall? It is only by
embedding the survey data in open-ended inductive exploration and audio observations that
investigators can determine if a counselor provided too much information to a low-literacy
patient, or alternatively used plain language to emphasize key points, checking frequently
for patient comprehension. Importantly, was the counselor able to do this as well by phone or
video? Thus, mixed methods illuminates important dynamics that informants may not be
consciously aware of.

Inclusion Criteria:Eligible participants include patients who

- visit the mammography, high risk or oncology clinics at Contra Costa County, Highland
or SFGH hospitals,

- are referred to genetic counseling services at SFGH by a community clinic through the
E-Referral system or are considered to be high risk based on their breast/ovarian
cancer genetics Referral Screening Tool (RST) score (≥ 2 checks)

- speak English, Spanish, or Cantonese

Investigators will also include two genetic counselors who provide services at SFGH and
UCSF.

Exclusion Criteria:

- do not speak English, Spanish, or Cantonese;

- are age 17 and under; and

- don't have a family history of cancer.