Validation of a Quality of Life Metric "Prolac-10" (Prolac-10)
|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: NCT04106531|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : March 4, 2020
|Condition or disease|
|Prolactinoma Prolactin-Producing Pituitary Tumor Pituitary Tumor Prolactinoma Macroadenoma Prolactinoma Microadenoma|
This is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. Patients will be consented before starting their medical regimen and complete the "Prolac-10" questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. The primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. Secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency.
The Prolac-10 metric is Copyright © 2019. The Ohio State University. Modification/derivative rights reserved, all other rights available.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- Validate the "Prolac-10" quality of life metric [ Time Frame: 13-weeks post medical therapy start date ]In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.
- Validate the test-retest characteristics of the Prolac-10 [ Time Frame: 13-weeks post medical therapy start date ]Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.
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): NCT04106531
|Contact: Josh Bolender, BS||614-685-8622||Joshua.Bolender@osumc.edu|
|Contact: Amy Minnema, MS||614-685-9827||Amy.Minnema@osumc.edu|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Joshua Bolender, BS 614-685-8622 Joshua.Bolender@osumc.edu|
|Contact: Amy Minnema, MS Amy.Minnema@osumc.edu|
|Principal Investigator: Douglas Hardesty, MD|
|Sub-Investigator: Daniel Prevedello, MD|
|Principal Investigator:||Douglas Hardesty, MD||Ohio State University|