A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly (BackSOM)

BackSOM Study: Qualitative Study in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Participants of this study are adults with GEP-NETs and/or acromegaly who were using the Ipsen lanreotide syringe and have transitioned in the last 6 months to the Pharmathen lanreotide syringe, having received at least two injections using the Pharmathen syringe.

GEP-NETs are abnormal growths that develop in the digestive system, including the stomach, intestines, and pancreas. These tumors arise from special cells called neuroendocrine cells, which are found in these organs and release hormones to regulate various bodily functions. GEP-NETs can be slow-growing, and symptoms may vary depending on their location and size.

Acromegaly is a condition where a person's body produces too much growth hormone. This excess hormone can cause certain body parts, like the hands, feet, and face, to enlarge over time. It typically occurs because of a tumor on the pituitary gland in the brain, which is responsible for regulating hormones. Acromegaly can lead to various health issues if not treated, but medications or surgery can often help manage the condition.

Long-acting somatostatin analogs (LA-SSAs) are indicated for patients with Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and acromegaly who are not eligible for surgery or when surgery fails to achieve remission.

Data for this study will be collected after the treatment switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe has occurred, using one round of one-to-one qualitative telephone and/or videoconference interviews with patients. Interviews will last 45 minutes and be carried out in the local language of the participant's country.

The main aim of this study is to capture the patient experience of the Ipsen lanreotide syringe and their experience with the Pharmathen lanreotide syringe.

Study Overview

• Status: Not yet recruiting
• Conditions: Acromegaly; Gastro-enteropancreatic Neuroendocrine Tumor

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Ipsen Clinical Study Enquiries; Phone Number: See e mail; Email: clinical.trials@ipsen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patients with GEP-NETs and/or acromegaly living in France, Italy, Spain, UK and the USA

Description

Inclusion Criteria:

• Adult patients;
• Reside in one of the following countries: France, Italy, Spain, UK and the USA;
• Self-report having a clinician-confirmed diagnosis of GEP-NET and/or acromegaly;
• Have transitioned from treatment with the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe within the last six months and have received a minimum of two injections with the Pharmathen lanreotide syringe;
• Had received a minimum of two injections with the Ipsen lanreotide syringe;
• Switched from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe only once;
• Are currently being treated with the Pharmathen lanreotide syringe;
• Are willing to provide written informed consent prior to data collection.

Exclusion Criteria:

• Any comorbid condition or factor that, in the opinion of the participants' recruiter or interviewer, may confound the participant's experience or otherwise interfere with their ability to participate fully in a qualitative interview (e.g., speech impediments);
• Participants who switched from independent-injection with the Ipsen lanreotide syringe to HCP-injection with the Pharmathen lanreotide syringe;
• Participants who switched from HCP-injection with the Ipsen lanreotide syringe to independent-injection with the Pharmathen lanreotide syringe;
• USA participants who independently inject (i.e., injections administered by the patient, a family member or friend) with the Ipsen lanreotide syringe and/or the Pharmathen lanreotide syringe.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients who independently inject	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients between disease indications	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Musculoskeletal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Hypothalamic Diseases; Bone Diseases; Pancreatic Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Stomach Neoplasms; Pancreatic Neoplasms; Acromegaly; Neuroendocrine Tumors; Intestinal Neoplasms
• Other Study ID Numbers: CLIN-52030-460

Plan for Individual participant data (IPD)

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

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

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