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HRQoL During PRRT in Patients With NETs

16. juni 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

756

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients receiving PRRT at Uppsala University Hospital.

Beskrivelse

Inclusion Criteria:

Receiving PRRT
NET diagnosis

Exclusion Criteria:

Not able to speak and read in Swedish or English.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change from baseline in health related quality of life at cycle 4 Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Uppsala University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. januar 2009

Primær fullføring (Faktiske)

15. mai 2018

Studiet fullført (Faktiske)

10. desember 2018

Datoer for studieregistrering

Først innsendt

13. mai 2022

Først innsendt som oppfylte QC-kriteriene

16. juni 2022

Først lagt ut (Faktiske)

22. juni 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)