Clinical trial NCT03613623: Acromegaly: Patient And Physician Perspectives
Official title: Acromegaly: Patient And Physician Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Chiasma, Inc.
First posted: 2018-08-03
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acromegaly will be sent invitations to participate. Their physicians will be identified at the time of participant enrollment and will be contacted by the study team for a telephone interview.

Brief 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.


Eligibility criteria: 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®)

Primary outcomes:
measure: Assess patient experiences with acromegaly treatments through patient questionnaires.
timeFrame: The questionnaire should take no more than 60 minutes per subject.
measure: Assess patient satisfaction with acromegaly treatments.
timeFrame: The questionnaire should take no more than 60 minutes per subject.
measure: Assess patients with acromegaly health-related quality of life.
timeFrame: The questionnaire should take no more than 60 minutes per subject.
Secondary outcomes:
measure: Assess the concordance between patient's and physician's perceptions of acromegaly control (with/without biochemical lab results),
timeFrame: The questionnaire should take no more than 60 minutes per subject.
measure: Assess the concordance between patient's and physician's perceptions of acromegaly treatment satisfaction.
timeFrame: The questionnaire should take no more than 60 minutes per subject.
measure: Assess the concordance between patient's and physician's perceptions of health-related quality of life.
timeFrame: The questionnaire should take no more than 60 minutes per subject.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Tulane University
name: Lizheng Shi, PhD, MsPharm
role: PRINCIPAL_INVESTIGATOR
References: