Acromegaly: Patient And Physician Perspectives

NCT03613623 | Completed

• 1 other identifier: 2018-879
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Assess the concordance between patient's and physician's perceptions of acromegaly control (with/without biochemical lab results),

  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 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 questionnaire should take no more than 60 minutes per subject.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Previous or current participant in Mycapssa® (octreotide capsules) trial
• Use of Pegvisomant (Somavert®) monotherapy
• Use of Pasireotide (Signifor®)

Sponsors & Collaborators

• Tulane University: lead
• Chiasma, Inc.: collaborator

Study Sites (1)

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Lizheng Shi, PhD, MsPharm

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 3, 2018
• Study Start: July 2, 2018
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)