HRQoL During PRRT in Patients With NETs

June 16, 2022 updated by: Uppsala University

Improved Health-related Quality of Life During Peptide Receptor Radionuclide Therapy in Patients With Neuroendocrine Tumours

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving PRRT at Uppsala University Hospital.

Description

Inclusion Criteria:

  • Receiving PRRT
  • NET diagnosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in health related quality of life at cycle 4
Time Frame: Baseline and before cycle 4 (each cycle is between 28-42 days)
EORTC QLQ-C30 and QLQ-GINET21 is validated, self-reported instrument assessing health related quality of life during the past week. The instruments are composed of both multi-item scales and singe-items measures. These include five functional scales, three symptom scales, a global health status scale, and six single items.
Baseline and before cycle 4 (each cycle is between 28-42 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2009

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRQoL PRRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe