Acromegaly Treatment Quality of Life Study

Completed

• Conditions: Acromegaly

• Registration Number: NCT01732406
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-22
• Study Start: 2013-01
• Primary Completion: 2016-12-19
• Study Completion: 2016-12-19
• Results First Submitted: 2017-11-02
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Results First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Age 18-90
• Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria

• Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
• Initiation or discontinuation of testosterone or estrogen within 3 months of entry
• Pregnant and nursing women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acromegaly Quality of Life (ACROQoL) Global Score	Cross-sectional at baseline	The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.

Secondary Outcome Measures

Name	Time	Method
The Gastrointestinal Quality of Life Index (GIQLI) Total Score	Cross-sectional at baseline	The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.
36-Item Short Form Survey Instrument (SF-36) Physical Health	Cross-sectional at baseline	The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.
36-Item Short Form Survey (SF-36) Mental Health Summary Score	Cross-sectional at baseline	The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States