Validation of a Quality of Life Metric "Prolac-10"

Ohio State University8 enrolled

Overview

This is a short-term validation study of a quality of life metric "Prolac-10" for patients diagnosed with a prolactinoma, undergoing new medical therapy.

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

Enrollment

Conditions

Prolactinoma Prolactin-Producing Pituitary Tumor Pituitary Tumor Prolactinoma Macroadenoma Prolactinoma Microadenoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging. * 18 years of age or older * The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent Exclusion Criteria: * Patient is a prisoner * Patient is not English speaking * Patient has been previously treated for prolactinoma * Patient is pregnant at time of diagnosis and treatment

Locations (1)

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Validate the "Prolac-10" quality of life metric

In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.

Time frame: 13-weeks post medical therapy start date

Secondary Outcomes

Validate the test-retest characteristics of the Prolac-10

Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.

Time frame: 13-weeks post medical therapy start date

Data from ClinicalTrials.gov

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