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

Genetic Counseling Clinical Trial

— GC3Modes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006913
• Other study ID #: UCSF-GC3-2021
• Secondary ID: R01CA197784-01A1
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: December 16, 2019

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1273
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Counseling

Intervention

Behavioral:
• In-person
At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.
• By phone
Patients in the phone arm will receive a scheduled call at their home.
• By video
Because low income patients are not likely to have video conference capability at home, this service will be offered at all three hospitals, and patients will have scheduled appointments to come to the hospital to receive counseling delivered through a computer.

Locations

Country	Name	City	State
United States	Contra Costa Regional Medical Center Health Services	Martinez	California
United States	Highland General Hospital	Oakland	California
United States	San Francisco General Hospital	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI), National Institutes of Health (NIH), University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Forman AD, Hall MJ. Influence of race/ethnicity on genetic counseling and testing for hereditary breast and ovarian cancer. Breast J. 2009 Sep-Oct;15 Suppl 1:S56-62. doi: 10.1111/j.1524-4741.2009.00798.x. Review. — View Citation

Green LW, Glasgow RE. Evaluating the relevance, generalization, and applicability of research: issues in external validation and translation methodology. Eval Health Prof. 2006 Mar;29(1):126-53. Review. — View Citation

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Hall MJ, Olopade OI. Disparities in genetic testing: thinking outside the BRCA box. J Clin Oncol. 2006 May 10;24(14):2197-203. Review. — View Citation

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Madlensky L. Is it time to embrace telephone genetic counseling in the oncology setting? J Clin Oncol. 2014 Mar 1;32(7):611-2. doi: 10.1200/JCO.2013.53.8975. Epub 2014 Jan 21. — View Citation

Narod SA, Foulkes WD. BRCA1 and BRCA2: 1994 and beyond. Nat Rev Cancer. 2004 Sep;4(9):665-76. Review. — View Citation

Nelson HD, Pappas M, Zakher B, Mitchell JP, Okinaka-Hu L, Fu R. Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2014 Feb 18;160(4):255-66. Review. — View Citation

Prevalence and penetrance of BRCA1 and BRCA2 mutations in a population-based series of breast cancer cases. Anglian Breast Cancer Study Group. Br J Cancer. 2000 Nov;83(10):1301-8. — View Citation

Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21. — View Citation

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Sussner KM, Jandorf L, Thompson HS, Valdimarsdottir HB. Interest and beliefs about BRCA genetic counseling among at-risk Latinas in New York City. J Genet Couns. 2010 Jun;19(3):255-68. doi: 10.1007/s10897-010-9282-4. Epub 2010 Feb 12. — View Citation

Vig HS, Wang C. The evolution of personalized cancer genetic counseling in the era of personalized medicine. Fam Cancer. 2012 Sep;11(3):539-44. doi: 10.1007/s10689-012-9524-8. — View Citation

Whittemore AS, Gong G, John EM, McGuire V, Li FP, Ostrow KL, Dicioccio R, Felberg A, West DW. Prevalence of BRCA1 mutation carriers among U.S. non-Hispanic Whites. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):2078-83. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in change scores among three counseling modes: Breast Cancer Knowledge Scale	Will measure knowledge of hereditary breast cancer information before and after delivery of counseling modes.	One week post counseling
Primary	Differences in change scores among three counseling modes: Impact of Events Scale	Will measure cancer-specific distress before and after delivery of counseling modes.	One week post counseling
Secondary	Differences in change scores among three counseling modes: Decisional Conflict Scale	Will measure decisional conflict before and after implementation of counseling modes.	One week post counseling
Secondary	Differences in change scores among three counseling modes: Perceived Stress Scale	Will measure general perceptions of stress before and after implementation of counseling modes.	One week post counseling
Secondary	Differences in change scores among three counseling modes: Breast/Ovarian Cancer Risk Perception and Worry Scale	Will measure breast cancer and ovarian cancer risk perception and worry before and after implementation of counseling modes.	One week post counseling
Secondary	Differences in change scores among three counseling modes: Perceptions of Risks and Benefits of Genetic Counseling Scale	Will measure perceptions of risks and benefits of genetic counseling before and after implementation of counseling modes.	One week post counseling
Secondary	Differences in change scores among three counseling modes: Genetic Counseling Satisfaction Scale	Will measure genetic counseling satisfaction before and after implementation of counseling modes.	One week post counseling