Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

Study Overview
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Brief Summary
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The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).

Official Title
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A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

Conditions
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Acromegaly

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion. Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form. Exclusion Criteria: Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria). Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acromegaly quality of life (AcroQol) questionnaire | The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery. | Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration | Descriptive analysis | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | 
| Clinical symptoms of acromegaly | Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | 
| Patient overall assessment of satisfaction from treatment | Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied. | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) | 
| Lanreotide injection interval (28, 42 or 56 days) | Summary of overall and by hormone control status. | Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation) |