Acromegaly Treatment Quality of Life Study

Massachusetts General Hospital126 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Acromegaly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Acromegaly Quality of Life (ACROQoL) Global Score

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.

Time frame: Cross-sectional at baseline

Secondary Outcomes

The Gastrointestinal Quality of Life Index (GIQLI) Total Score

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.

Time frame: Cross-sectional at baseline

36-Item Short Form Survey Instrument (SF-36) Physical Health

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.

Time frame: Cross-sectional at baseline

36-Item Short Form Survey (SF-36) Mental Health Summary Score

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.

Time frame: Cross-sectional at baseline

Data from ClinicalTrials.gov

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