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Testing a Culturally Adapted Telephone Genetic Counseling Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959267
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Hackensack Meridian Health
Information provided by (Responsible Party):
Alejandra Hurtado de Mendoza, Georgetown University

Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Hereditary Breast Cancer Behavioral: Telephone Genetic Counseling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will conduct a two-arm Randomized Controlled Trial (RCT) comparing Telephone Genetic Counseling in Spanish vs. Usual care.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020


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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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).

  2. Communication [ Time Frame: Three months after baseline ]
    Communication outcomes will be quantitatively measured following RIAS medical interaction coding guidelines (e.g., patient centeredness).

  3. 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"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on the self-representation of gender identity
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959267


Locations
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United States, District of Columbia
Capital Breast Care Center
Washington, District of Columbia, United States, 20003
United States, New Jersey
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
United States, Virginia
Nueva Vida
Alexandria, Virginia, United States, 22314
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Georgetown University
Hackensack Meridian Health
Investigators
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Principal Investigator: Alejandra Hurtado de Mendoza, PhD Georgetown University

Publications:

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Responsible Party: Alejandra Hurtado de Mendoza, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03959267     History of Changes
Other Study ID Numbers: KL2TR001432 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandra Hurtado de Mendoza, Georgetown University:
Latinas
Survivors
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases