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

Terminated

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

• Registration Number: NCT04106531
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2019-10-15
• Status Verified: 2023-06
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States