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NCT Number: NCT06253897

A Study to Understand Participant's Experiences 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.

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Key information

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pearl IRB

Indianapolis, Indiana, 46225, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

Secondary outcomes

  1. Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

  2. Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

  3. Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

  4. Qualitative interview: experiences that are unique to patients who independently inject

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

  5. Qualitative interview: experiences that are unique to patients between disease indications

    Time frame: Up to 6 months after treatment switch

    Interview with a duration of 45 minutes.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: BackSOM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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