Acromegaly: Patient And Physician Perspectives

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.

Study Overview

• Status: Completed
• Conditions: Acromegaly

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane School of Public Health and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 94 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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®)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients; Patients diagnosed with acromegaly and currently taking long-acting somatostatin analogues for treatment.
Physicians; Physicians for those treating the patients enrolled in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Chiasma, Inc.
• Investigators: Principal Investigator: Lizheng Shi, PhD, MsPharm, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: 2018-879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No