Efficacy of Point Of Service Testing in MBC (EPOST MBC)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03983577|
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Breast Cancer||Other: Point of service delivery model||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Efficacy of Point Of Service Testing in Metastatic Breast Cancer|
|Actual Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Point of service delivery model
After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model.
Other: Point of service delivery model
Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.
- Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention. [ Time Frame: 24 months ]Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.
- Overall participant satisfaction [ Time Frame: 24 months ]Patient satisfaction will be assessed with an adapted Genetic Counseling Satisfaction Scale (aGCSS). Each item is scored from 1- 5, with 1 being strongly disagree and 5 being agree strongly. The scores are added then divided by 5 to give a mean score.
- Clinical decisional conflict score [ Time Frame: 24 months ]Decisional conflict will be assessed using the Decisional Conflict Scale (Sure Test Version). The 4 items are summed. Scores range from 0 (extremely high decisional conflict) to 4 (no decisional conflict). A score of less than or equal to 3 indicates decisional conflict.
- Overall participant anxiety [ Time Frame: 24 months ]Participant anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS-Anxiety scale). Each item is scored between 0- 3 with a total score between 0- 21 possible. Scores of 0-7 indicates normal; scores of 8-10 indicates borderline abnormal; scores of 11-21 indicates abnormal.
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): NCT03983577
|Contact: CT Nurse Navigatoremail@example.com|
|United States, Kansas|
|The University of Kansas Cancer Center, Westwood Campus||Recruiting|
|Kansas City, Kansas, United States, 66205|
|Contact: Clinical Trials Nurse Navigator 913-945-7552 firstname.lastname@example.org|
|Principal Investigator:||Lauren Nye, MD||University of Kansas|