Acromegaly: Patient And Physician Perspectives

Acromegaly Clinical Trial

Official title:

Acromegaly: Patient And Physician Perspectives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613623
• Other study ID #: 2018-879
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to assess the experiences of individuals with acromegaly who are receiving injections as part of their treatment regimen. Another objective of the study is to compare the patients' perception with their doctors' perceptions. The answers are important to help researchers and physicians understand what it is really like to take currently available treatments so that they can make efforts to improve patients' healthcare experiences, reduce treatment burden and, ultimately, improve patient's quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 94 Years

Eligibility

Inclusion Criteria:

• Age >=18 years-old and <95 years-old

• Patient self-reported acromegaly diagnosis which will be further confirmed by a knowledge screening based on current medications and doses

• Currently on injectable Somatostatin analogues (SSA), Sandostatin® LAR or Somatuline® Depot, for >=12 months

• Have not had a change in dosage of their acromegaly treatment at the time of or since their last office visit

• Have seen their treating acromegaly physician within the past 12 +/-2 months NOTE:

This timeframe allows two additional months for scheduling an appointment with their physician, since most patients should see their acromegaly physician at least once every 12 months

• Ability to read and understand English

• Live and receive acromegaly treatments in the US

• Willing to provide signed informed consent

Exclusion Criteria:

• Previous or current participant in Mycapssa® (octreotide capsules) trial

• Use of Pegvisomant (Somavert®) monotherapy

• Use of Pasireotide (Signifor®)

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
United States	Tulane School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	Chiasma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess patient experiences with acromegaly treatments through patient questionnaires.	The primary objective of this study is to assess the experience of patients treated with SSA injections in the United States. Patients will be asked about previous and current acromegaly treatments they have taken from the time of diagnosis to the current day they are completing the survey.	The questionnaire should take no more than 60 minutes per subject.
Primary	Assess patient satisfaction with acromegaly treatments.	The primary objective of this study is to assess the treatment satisfaction of patients treated with SSA injections in the United States. Patients will be asked about previous and current acromegaly treatments they have taken from the time of diagnosis to the current day they are completing the survey.	The questionnaire should take no more than 60 minutes per subject.
Primary	Assess patients with acromegaly health-related quality of life.	The primary objective of this study is to assess the health-related quality of life for patients treated with SSA injections in the United States. Patients will be asked about their current quality of life and how acromegaly and acromegaly treatments may affect their quality of life from time of diagnosis to time of completing the survey.	The questionnaire should take no more than 60 minutes per subject.
Secondary	Assess the concordance between patient's and physician's perceptions of acromegaly control (with/without biochemical lab results),	The second objective of this study is to compare patients' perception with those of their physicians in terms of aspects such as acromegaly control, treatment satisfaction, and health-related quality of life (HRQoL).	The questionnaire should take no more than 60 minutes per subject.
Secondary	Assess the concordance between patient's and physician's perceptions of acromegaly treatment satisfaction.	The second objective of this study is to compare patients' perception with those of their physicians in terms of aspects such as acromegaly treatment satisfaction.	The questionnaire should take no more than 60 minutes per subject.
Secondary	Assess the concordance between patient's and physician's perceptions of health-related quality of life.	The second objective of this study is to compare patients' perception with those of their physicians in terms of aspects such as health-related quality of life (HRQoL).	The questionnaire should take no more than 60 minutes per subject.