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

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04106531

Collaborator

(none)

Enrollment

Location

50.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolactinoma Prolactin-Producing Pituitary Tumor Pituitary Tumor Prolactinoma Macroadenoma Prolactinoma Microadenoma

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Douglas Hardesty, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Douglas Hardesty, Assistant Professor, Neurological Surgery, Ohio State University

ClinicalTrials.gov Identifier:

NCT04106531

Other Study ID Numbers:

2019H0375

First Posted:

Sep 27, 2019

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pituitary Neoplasms

Prolactinoma

Pituitary Diseases

Study Results

No Results Posted as of Jun 22, 2021