Testing a Culturally Adapted Telephone Genetic Counseling Intervention
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|ClinicalTrials.gov Identifier: NCT03959267|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hereditary Breast Cancer||Behavioral: Telephone Genetic Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|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)|
|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 :||October 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- Communication [ Time Frame: Three months after baseline ]Communication outcomes will be quantitatively measured following RIAS medical interaction coding guidelines (e.g., patient centeredness).
- 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"
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
|Contact: Alejandra Hurtado de Mendoza, PhDemail@example.com|
|Contact: Sara Gómez Trillos, BAfirstname.lastname@example.org|
|United States, District of Columbia|
|Capital Breast Care Center||Recruiting|
|Washington, District of Columbia, United States, 20003|
|Contact: Nathaly Gonzalez 202-784-2705 email@example.com|
|Contact: Lucille Adams-Campbell, PhD 202-687-5367 firstname.lastname@example.org|
|United States, New Jersey|
|Hackensack Meridian Health||Terminated|
|Hackensack, New Jersey, United States, 07601|
|United States, Virginia|
|Alexandria, Virginia, United States, 22314|
|Contact: Claudia Campos 202-223-9100 email@example.com|
|Contact: Astrid Jimenez 202-223-9100 firstname.lastname@example.org|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23284|
|Contact: Yvonne Cummings 804-828-0643 Yvonne.Cummings@vcuhealth.org|
|Contact: Vanessa Sheppard, PhD Vanessa.Sheppard@vcuhealth.org|
|Principal Investigator:||Alejandra Hurtado de Mendoza, PhD||Georgetown University|