HRQoL During PRRT in Patients With NETs

NCT05427032 | Completed

• 1 other identifier: HRQoL PRRT
• Study Type: observational
• Target: 756
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroendocrine Tumors; Quality of Life; Peptide Receptor Radionuclide Therapy

Keywords

NETs; PRRT; HRQoL

Outcome Measures

Primary Outcomes (1)

• Change from baseline in health related quality of life at cycle 4

  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)

Eligibility Criteria

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

Study Population

Patients receiving PRRT at Uppsala University Hospital.

You may qualify if:

• Receiving PRRT
• NET diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 22, 2022
• Study Start: January 10, 2009
• Primary Completion: May 15, 2018
• Study Completion: December 10, 2018
• Last Updated: June 22, 2022

Record last verified: 2022-06