Acromegaly Treatment Quality of Life Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

Conditions
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Acromegaly

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acomegaly with Pegvisomant<br>Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly. | |
| Acromegaly with somatostatin analog<br>Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly | |
| Active Acromegaly<br>Patients not on drugs for treatment of acromegaly | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Cross-sectional at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Cross-sectional at baseline |