HRQoL During PRRT in Patients With NETs

NCT ID: NCT05427032

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 756 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-10
• Study Completion Date: 2018-12-10

Brief Summary

Neuroendocrine tumours (NETs) can arise in different locations in the body, and may give rise to hormonal symptoms, which may affect the patients' health-related quality of life (HRQoL). Up to four cycles of peptide receptor radionuclide therapy (PRRT) have been shown effective for symptom alleviation and prolonging survival. The aim of this study is to assess the patient's perspective, regarding changes in their HRQoL during, and at long-term follow-up after, PRRT. Patients with NET will rate their HRQoL before PRRT cycles one and four, and 1-8 years after PRRT. The patients' HRQoL will be compared to a matched reference population. The investigators hope that this study will reveal specific care needs for patients wiht NET and may provide information that will make it possible to deliver a more person-centered care.

Detailed Description

The inclusion criteria for PRRT were tumour somatostatin receptor expression higher than that in the normal liver found on somatostatin receptor scintigraphy (Krenning score 3 and 4), or on 68Ga-DOTATOC positron emission tomography (PET), and sufficient bone marrow, liver and kidney function. DOTATATE was labelled in house with 177Lu (IDB Holland BV, Noord Brabant, Netherlands). Up to nine cycles were given, yet a majority of patients received four cycles of PRRT.

The patients' medical records were reviewed regarding functional status (functioning versus non-functioning tumours), gender, age at diagnosis and at 1st PRRT, marital and employment status, PRRT cycles received, previous treatments and body mass index (BMI).

HRQoL was assessed using the questionnaires for cancer in general, EORTC QLQ-C30, and the gastrointestinal NET-specifically EORTC QLQ-GINET21 at every cycle.

From a large random sample (n=4,910) of the Swedish adult population, a reference population was extracted. They all had chronical diseases (diabetes, cardiac, respiratory, renal or other specified conditions) and were age and gender matched. The reference population completed only the QLQ-C30 questionnaire.

In order to investigate how HRQoL developed during the eight years after PRRT, the questionnaires were sent to 58 patients.

Conditions

Neuroendocrine Tumors; Quality of Life; Peptide Receptor Radionuclide Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Receiving PRRT
• NET diagnosis

Exclusion Criteria

• Not able to speak and read in Swedish or English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HRQoL PRRT

Identifier Type: -

Identifier Source: org_study_id