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Testing a Culturally Adapted Telephone Genetic Counseling Intervention

NCT03959267CompletedNAINTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Georgetown University

Enrollment

Start Date

2017-07-07

Completion Date

2021-01-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Telephone Genetic Counseling

Conditions

Breast CancerHereditary Breast Cancer

Eligibility

Age Range

21 Years – 90 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Number of participants that receive genetic cancer risk assessment (GCRA)

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

Time frame: Three months after baseline

Secondary Outcomes

Change in knowledge

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.

Time frame: Change from baseline to three months after baseline

Change in decisional conflict

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.

Time frame: Change from baseline to three months after baseline

Distress

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.

Time frame: At baseline

Decision Satisfaction

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.

Time frame: Three months after baseline

Satisfaction with counseling

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.

Time frame: Three months after baseline

Number of participants that receive genetic testing

The RA will conduct a follow-up call to inquire whether participants pursued genetic testing or not.

Time frame: Three months after baseline

Locations

Capital Breast Care Center, Washington D.C., United States

Hackensack Meridian Health, Hackensack, United States

Nueva Vida, Alexandria, United States

Virginia Commonwealth University, Richmond, United States

Linked Investigators

Alejandra Hurtado de Mendoza

Kristi D Graves

Marc D. Schwartz

Sara Gómez-Trillos

Susan T Vadaparampil