Clinical trial NCT05427032: HRQoL During PRRT in Patients With NETs
Official title: Improved Health-related Quality of Life During Peptide Receptor Radionuclide Therapy in Patients With Neuroendocrine Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Quality of Life
Peptide Receptor Radionuclide Therapy
Keywords: NETs
PRRT
HRQoL
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 756
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: Patients receiving PRRT at Uppsala University Hospital.

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.

Eligibility criteria: Inclusion Criteria:

* Receiving PRRT
* NET diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in health related quality of life at cycle 4
timeFrame: Baseline and before cycle 4 (each cycle is between 28-42 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: