Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel

NCT03562091 | Completed

• 1 other identifier: A-FR-52030-371
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Absolute variation on the score (standardized on a scale from 0 to 100) of the 3 targeted dimensions (disease, treatments and supportive care) of the self-administered Quality of Life Questionnaire (QLQ) QLQINFO25

  Change from Baseline to Month 6

Secondary Outcomes (6)

• Change from baseline to Month 3 of the 3 targeted dimensions (disease, treatments and supportive care (ie, other services)) of QLQ-INFO25 self-administered questionnaire

  Change from Baseline to Month 3

• Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint

  Change from Baseline to Month 3 and 6

• Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire

  Change from Baseline to Month 3 and Month 6

• Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET)

  Change from Baseline to Month 3 and to Month 6

• Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET

  Change from Baseline to Month 3 and to Month 6

Interventions

Data collection OTHER

The study is an observational evaluation that does not affect physician practices, the physician-patient relationship, or the care of subjects. The prescriptions will be decided prior to inclusion of the subject into the study. The information will be recorded using the data available in the medical file or collected during the visit (as part of the routine subject management).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with Gastroenteropancreatic neuroendocrine tumor (GEPNET) from Primary care clinics

You may qualify if:

• Gastroenteropancreatic neuroendocrine tumor (GEPNET), histologically proven, grade
• or 2,
• Subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices
• Having consented in writing to his/her data being accessed for participation in the study.

You may not qualify if:

• Previously treated by lanreotide autogel
• Simultaneously participating in a clinical trial

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 19, 2018
• Study Start: July 20, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

FR (1)