Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China

Withdrawn

• Conditions: Acromegaly

• Registration Number: NCT05184231
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the protocol is to achieve an in-depth understanding of the current satisfaction status of somatostatin analogue (SSA) treatment for acromegaly through patient and physician surveys.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2022-01-11
• Study Start: 2023-02-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

For Patients:

• Age 18 years or older
• Diagnosed with acromegaly
• Receiving current SSA injections for acromegaly treatment for at least 3 months
• Signed electronic Informed Consent Form (eICF)

For Physicians:

• Licensed endocrinologists or neurosurgeons
• Having prescribed SSAs for at least five patients with acromegaly in the past 6 months
• Signed eICF

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Exclusion Criteria

• Patients will not be included in the survey if they meet any of the following criteria:
• Patients who are not able to successfully complete the questionnaire independently
• Pregnant patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall patient satisfaction with SSA treatment.	During the whole study period (approximately 3 months).	To be assessed by four levels of satisfaction including very satisfied, satisfied, dissatisfied, and very dissatisfied

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction with symptom control of SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with symptom control of SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with frequency of administration of SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with injection site reactions of SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with convenience of administration of SSA treatment	During the whole study period (approximately 3 months).
Physician satisfaction with frequency of administration of SSA treatment	During the whole study period (approximately 3 months).
Physician satisfaction with adverse reactions to SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with mode of administration of SSA treatment	During the whole study period (approximately 3 months).
Patient satisfaction with adverse reactions to SSA treatment	During the whole study period (approximately 3 months).
Physician satisfaction with injection site reactions of SSA treatment	During the whole study period (approximately 3 months).
Aspects of patient concern before initiating SSA treatment	During the whole study period (approximately 3 months).	The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned.
Physician overall satisfaction with SSA treatment.	During the whole study period (approximately 3 months).	The satisfaction rate is calculated as the proportion of physicians who reported to be satisfied or very satisfied with the prescribed SSA treatment.
Physician satisfaction with mode of administration of SSA treatment	During the whole study period (approximately 3 months).
Physician satisfaction with convenience of administration of SSA treatment	During the whole study period (approximately 3 months).
Aspects of physician concern before prescribing SSA treatment	During the whole study period (approximately 3 months).	The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned.
Overall patient satisfaction with SSA treatment: satisfied versus dissatisfied with their SSA treatment.	During the whole study period (approximately 3 months).	The patient satisfaction will be categorized as binary variables including satisfied (very satisfied and satisfied) versus dissatisfied (dissatisfied and very dissatisfied).