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

Pituitary Tumor Clinical Trial

— Prolac-10  

Official title:

Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04106531
• Other study ID #: 2019H0375
• Status: Terminated
• Start date: October 15, 2019
• Est. completion date: June 13, 2023

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Prolactin-Producing Pituitary Tumor
• Prolactinoma
• Prolactinoma Macroadenoma
• Prolactinoma Microadenoma

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13-weeks post medical therapy start date
Secondary	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.	13-weeks post medical therapy start date