AcromegalyNCT03613623
Acromegaly: Patient And Physician Perspectives
An observational study of Acromegaly, run by Tulane University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Acromegaly
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previous or current participant in Mycapssa® (octreotide capsules) trial
- Use of Pegvisomant (Somavert®) monotherapy
- Use of Pasireotide (Signifor®)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane School of Public Health and Tropical Medicine
New Orleans, Louisiana, 70112
About this study
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
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 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).
Measured: 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.
Measured: 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).
Measured: The questionnaire should take no more than 60 minutes per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start2 Jul 2018
- Primary completion1 Dec 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Tulane UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiasma, Inc.
- Responsible party
- Principal investigator, Lizheng Shi, Tulane University
- Investigators
- Lizheng Shi, PhD, MsPharm, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613623
- Sponsor's protocol ID
- 2018-879
- Status last verified
- Oct 2020
- First submitted
- 2 Jul 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acromegaly: Patient And Physician Perspectives
- ClinicalTrials.gov ID
- NCT03613623
- Acronym / sponsor ID
- 2018-879
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Chiasma, Inc.
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Previous or current participant in Mycapssa® (octreotide capsules) trial
- Use of Pegvisomant (Somavert®) monotherapy
- Use of Pasireotide (Signifor®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess patient experiences with acromegaly treatments through patient questionnaires.
Time frame: The questionnaire should take no more than 60 minutes per subject.
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.
Assess patient satisfaction with acromegaly treatments.
Time frame: The questionnaire should take no more than 60 minutes per subject.
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.
Assess patients with acromegaly health-related quality of life.
Time frame: The questionnaire should take no more than 60 minutes per subject.
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.
3 secondary outcomes
Assess the concordance between patient's and physician's perceptions of acromegaly control (with/without biochemical lab results),
Time frame: 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.
Time frame: 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.
Time frame: The questionnaire should take no more than 60 minutes per subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Undecided
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An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizheng Shi, PhD, MsPharm principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess patient experiences with acromegaly treatments through patient questionnaires. (time frame: The questionnaire should take no more than 60 minutes per subject.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.