Testing a Culturally Adapted Telephone Genetic Counseling Intervention

August 30, 2021 updated by: Alejandra Hurtado de Mendoza, Georgetown University

Testing a Culturally Adapted Telephone Genetic Counseling Intervention to Enhance Genetic Risk Assessment in Underserved Latinas at Risk of Hereditary Breast and Ovarian Cancer

Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian cancer (HBOC) can inform treatment and risk management decisions and improve breast cancer outcomes. However, Latina women underuse GCRA services, which may increase breast cancer disparities. This study will adapt and test the impact of a Culturally Adapted Telephone Genetic Counseling Intervention to enhance the use and quality of genetic counseling services for underserved Latina women at-risk of hereditary breast and ovarian cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SPECIFIC AIMS Women with BRCA1/2 mutations have a 50-80% and 15-40% lifetime risk of developing breast and ovarian cancer, respectively.1 Breast cancer survivors with BRCA1/2 mutations are three times more likely to develop contralateral breast cancer than non-carriers.2 The National Comprehensive Cancer Network (NCCN) recommends referral for hereditary breast and ovarian cancer (HBOC) genetic cancer risk assessments (genetic counseling and consideration of genetic testing; GCRA) for women at high risk of carrying a mutation.3 A positive genetic test can inform treatment in newly diagnosed breast cancer patients and management in survivors and unaffected women.4 Latinas have a significantly higher BRCA1/2 gene mutation prevalence than non-Latina Whites,5 yet they are 4-5 times less likely to have GCRA.6 Reasons for lower GCRA use include access, language barriers, and psychosocial factors.7-12 Fewer than 5% of the already limited number of genetic counselors in the US speak a language other than English.13 Developing alternative strategies to enhance GCRA access is important to ensure national guidelines are met and to reduce disparities.5,14

Our preliminary data suggest that GCRA referral guidelines are not consistently met among high-risk Latinas, many of whom are often not offered GCRA or are offered testing without counseling due to access and language barriers. Alternative strategies for delivery of genetic services, such as telephone genetic counseling (TGC), are safe, acceptable, and effective in both urban and rural populations.15,16 TGC can be a viable alternative strategy to in-person counseling for Latinas given that (1) TGC can enhance access to comprehensive genetic counseling by reducing cost and logistic barriers, which are especially important in underserved groups17; (2) TGC can also maximize the reach and access to the few Spanish-speaking genetic counselors in the US.13 Our initial data indicate that providers will increase the number of referrals to GCRA if Spanish genetic counseling is available. Thus, by overcoming access and language barriers, Spanish TGC can increase GCRA access among this high-risk yet underserved population.

Beyond addressing access and language barriers, Spanish TGC may enhance the quality of information conveyed during counseling. Given the shortage of Spanish-speaking genetics professionals, English-speaking counselors use phone or in-person interpretation services with Spanish-speaking patients. Unfortunately, the quality of the information conveyed via Spanish interpreters is suboptimal.18 Interpreters do not have the requisite genetics expertise and may reduce, omit, or revise content.19 An initial study found that during HBOC genetic counseling, interpreters translated probabilistic statements as definitive or shortened and altered key explanations of risk information.18 In addition to potential content inaccuracies, interpretation typically precludes 'small talk' that helps build rapport.20 Our preliminary data align, suggesting both Latinas and providers report concerns about accuracy and rapport in sessions with interpreters. Spanish TGC could improve counseling quality by eliminating the need for interpretation for Latinas who are referred to and attend counseling.

The investigators will compare evidence-based TCG developed by members of my mentoring team16,21 to usual care (UC) among high-risk, Spanish-speaking Latinas. The investigators anticipate that usual care will consist of either no referral to GCRA, offer of direct genetic testing without counseling, or genetic counseling with interpretation. Guided by the Ottawa Framework for Informed Decision Making22 the investigators propose a two phased mixed methods study. In Phase I, the investigators will conduct interviews with high-risk Latinas (n=15) to adapt the intervention materials using the Learner Verification and Revision frame.23 In Phase II, the investigators will use a cluster randomized design with four sites randomized to Spanish TGC (n=2 sites) or UC (n=2 sites). Our primary outcome is genetic counseling uptake among 60 high risk Latinas. Genetic testing uptake will be a secondary outcome. Among women who receive genetic counseling either through TGC or with an interpreter, the investigators will assess counseling quality by evaluating women's knowledge, counseling satisfaction, and communication in 20 audiotaped sessions. The investigators will assess communication using the gold standard RIAS quantitative coding system 24 and qualitative discourse analysis.25 Participants will complete assessments at baseline, post-counseling, and at 3 months. The investigators aim to:

Aim 1. Culturally adapt the TGC booklet and genetic counseling protocols. Aim 2. Evaluate the impact of TGC vs. UC on GCRA access. Participants randomized to TGC (vs. UC) will have H.2.1. higher genetic counseling uptake H.2.2. higher testing uptake 3 months post intervention.

Aim 3. Assess the quality of genetic counseling sessions among participants who attend the sessions. H.3.1. Participants randomized to TGC (vs. UC) will have higher HBOC knowledge and satisfaction and lower decisional conflict and distress. H.3.2. The investigators will explore communication patterns in 20 TGC and genetic counseling sessions with an interpreter using quantitative and qualitative methods.

Given access barriers and the shortage of Spanish speaking genetic counselors, adapting and translating TGC intervention is a promising strategy that could reduce disparities by broadening the reach and accessibility to genetic counseling while enhancing the quality of the service.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Capital Breast Care Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Health
    • Virginia
      • Alexandria, Virginia, United States, 22314
        • Nueva Vida
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Self-identify as Latina/Hispanic
  • Be 21 years old or older
  • Be at risk of hereditary breast and ovarian cancer because of personal and/or family medical history according to NCCN guidelines
  • Be diagnosed with breast cancer, and have completed active treatment (i.e., chemotherapy, radiation, surgeries)
  • Be able to provide the name and contact information of a primary healthcare provider, whom they see at least once a year
  • Speak and read Spanish.

Exclusion Criteria:

  • Do not identify as Latina/Hispanic.
  • Younger than 21 years old.
  • Do not meet current national guidelines to be considered at risk for hereditary breast and ovarian cancer.
  • Has been diagnosed with ovarian cancer or stage IV breast cancer.
  • Has not completed active treatment (e.g., surgery, chemotherapy, radiation).
  • Is not able to provide the name and contact information of the primary healthcare provider. This must be someone whom they have seen at least once during the past 12 months.
  • Cannot provide consent to participate.
  • Has received genetic counseling by a genetics professional (e.g., genetic counselor or genetics nurse).
  • Has participated in a previous phase of this study.
  • Cannot provide a copy of their genetic test results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Participants will continue with their usual medical care. Usual care may vary at different sites. Based on the investigator's preliminary data usual care can result in not GCRA referral, referral directly to testing, or referral to genetic counseling with an interpreter. The investigators will document usual care for participants from the sites randomized to usual care.
Other: Telephone Genetic Counseling
Participants will receive telephone genetic counseling with the culturally adapted protocol and booklet
Behavioral: Telephone Genetic Counseling
A genetic counselor fluent in Spanish (see letter of support) will conduct the TGC. The TGC intervention consists of two sessions. Prior to the sessions the investigators will mail participants the education materials with information to be reviewed prior to the genetic counseling session and a set of visual aids that the counselor will refer to during the session to facilitate the understanding of the information conveyed in the session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that receive genetic cancer risk assessment (GCRA)
Time Frame: Three months after baseline
The RA will conduct a follow-up call to inquire whether participants randomized to Usual Care completed a GCRA appointment and to gather information about the place where the appointment was held and name of the genetic counselor
Three months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge
Time Frame: Change from baseline to three months after baseline
The investigators will measure knowledge with the 13-item Breast Cancer Genetic Knowledge Scale by Erblich et al., 2005 answered in a True/False/Do not know format. Answers are recoded to correct or incorrect. The number of correct responses are added to create a score ranging from 0-13. Higher scores mean higher breast cancer genetics knowledge.
Change from baseline to three months after baseline
Change in decisional conflict
Time Frame: Change from baseline to three months after baseline
The investigators will measure decisional conflict with the 16-item Decisional-Conflict Scale by O'Connor AM, 1995. The scale is rated on a 1-5 scale. Answers are aggregated to yield a score from 16-80. The higher the final score, the least decisional conflict.
Change from baseline to three months after baseline
Distress
Time Frame: At baseline
The investigators will measure distress using the Patient Reported Outcomes Measurement Information System (PROMIS) short anxiety scale by Pilkonis, P.A., Choi, S.W., Reise, S.P., Stover, A.M., Riley, W.T., Cella, D., on behalf of the PROMIS Cooperative Group. (2011). The scale is 1 - 6 scale, in which higher scores mean higher distress.
At baseline
Decision Satisfaction
Time Frame: Three months after baseline
The investigators will measure satisfaction with healthcare decisions using the 5 item Satisfaction with healthcare decisions scale by Holmes-Rovner M, Kroll J, Schmitt N, et al., 1996. The scale answers go from 1- 5. The higher scores represent higher satisfaction with healthcare decisions.
Three months after baseline
Satisfaction with counseling
Time Frame: Three months after baseline
The investigators use a scale developed by their team, which have been used in prior published work (see DeMarco TA, Peshkin BN, Mars BD, Tercyak KP., 2004 and Tercyak KP, Demarco TA, Mars BD, Peshkin BN., 2004). This 5-item scale is answered from 1-5, with higher scores signifying higher satisfaction with counseling.
Three months after baseline
Number of participants that receive genetic testing
Time Frame: Three months after baseline
The RA will conduct a follow-up call to inquire whether participants pursued genetic testing or not.
Three months after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication
Time Frame: Three months after baseline
Communication outcomes will be qualitatively measured using discourse analysis (e.g., "Number of patient-initiated questions" will be coded following guidelines).
Three months after baseline
Communication
Time Frame: Three months after baseline
Communication outcomes will be quantitatively measured following RIAS medical interaction coding guidelines (e.g., patient centeredness).
Three months after baseline
Acceptability
Time Frame: Thee months after baseline
Using a 12-item scale, the RA will assess whether participants perceived the genetic counseling session as acceptable or not based on answers from 1 - 10 and "Strongly disagree" to "Strongly agree"
Thee months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Hackensack Meridian Health

Investigators

  • Principal Investigator: Alejandra Hurtado de Mendoza, PhD, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KL2TR001432 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Telephone Genetic Counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe