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

The Ohio State University

Status: Terminated

Conditions: Prolactinoma Microadenoma; Prolactinoma; Pituitary Tumor; Prolactinoma Macroadenoma; Prolactin-Producing Pituitary Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT04106531

2019H0375

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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