Clinical trial NCT06253897: A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly
Official title: BackSOM Study: Qualitative Study in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro-enteropancreatic Neuroendocrine Tumor
Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;
timeFrame: Up to 6 months after treatment switch
Secondary outcomes:
measure: Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe
timeFrame: Up to 6 months after treatment switch
measure: Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe
timeFrame: Up to 6 months after treatment switch
measure: Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe
timeFrame: Up to 6 months after treatment switch
measure: Qualitative interview: experiences that are unique to patients who independently inject
timeFrame: Up to 6 months after treatment switch
measure: Qualitative interview: experiences that are unique to patients between disease indications
timeFrame: Up to 6 months after treatment switch
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Pearl IRB
state: Indiana
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: