Pituitary Tumor, Prolactinoma, Prolactinoma Macroadenoma, Prolactinoma Microadenoma, Prolactin-Producing Pituitary Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate the Prolac-10 quality of life metric | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validate the test-retest characteristics of the Prolac-10 | 13-weeks post medical therapy start date | Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency. |
Countries
United States
Outcome results
None listed