Fatigue and Quality of Life in Patients With Neuroendocrine Neoplasia

September 14, 2020 updated by: Gitte Dam, University of Aarhus

Numerous studies describe HRQoL in other cancer types, whereas only sparse research has been done in NEN patients. We wish to investigate HRQol in NEN patients. Using a validated generic tool with normative values derived from a background population, allows us to compare the values healthy controls.

Methods

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The diagnosis of cancer and living with cancer has an impact on patients' HRQoL. Numerous studies describe HRQoL in other cancer types, whereas only sparse research has been done in NEN patients.

Previous studies concerning the effect of cancer on HRQoL have been useful and help clinicians regulate treatment regimens in other cancer types. In advanced cancer patients, it is shown that Global QoL, physical, role, and emotional functioning improves during HPN and it wasin patients who are candidates for HPN according to the European guidelines.

Moreover, patients with laryngeal cancer who are offered partial or total laryngectomy experience a significant and fast decline in HRQoL compared to those who are offered transoral laser microsurgery. This study has improved clinician and patient decision-making.

Previous studies investigating HRQoL in NEN patients have methodological limitations; no reference groups, limited number of patients or including a heterogenos group of patietns. This lack of methodological quality may explain the inconsistency in the HRQoL results found in previous NEN studies.To our knowledge, only a few cross-sectional studies of larger patient groups compared to a background population have been published.

Both HRQoL and fatigue are likely to be affected in NEN patients. Using a validated generic tool with normative values derived from a background population, allows us to compare the values healthy controls.

Aim

  • To quantify HRQoL and fatigue in a cross-sectional study (Study A) of a large group of patients with NEN
  • To investigate the immediate effect of diagnosis and somatostatin-analogue treatment on new patients. A prospective study over the course of three months (Study B)
  • To investigate the change in HRQoL and fatigue during follow-up. (a three year follow-up will be performed beyond this research year)

Hypothesis

  • HRQoL will be significantly lower and fatigue significantly higher in NEN patients compared to the general population
  • HRQoL will be significantly lower and fatigue significantly higher in NEC patients compared to NET patients.
  • Newly diagnosed patients with NET starting somatostatin analogue treatment will improve their HRQoL and reduce fatigue after a follow-up period of three months.
  • In patients with neuroendocrine neoplasia, HRQoL will remain unchanged in patients with stable disease and derease in patients with disease progression.

Methods

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Gitte Dam
        • Contact:

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newly diagnosed NET and NEC patients All patients will be recruited from the department of Hepatology and Gastroenterology and at the Department of Oncology, at Aarhus University Hospital. Inclusion will happen at standard follow-up visits for patients in Cohort A and at first visit/time of diagnosis and at three-month follow-up for patients in Cohort B. Inclusion time is expected to be 9-10 months.

Description

Inclusion Criteria: all newly diagnosed NET and NEC patietns Exclusion Criteria:None

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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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NET

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:
Newly diagnosed NET
A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.
Drug: Somatostatin analog
120 mg ipstyl every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NET and NEC
Time Frame: 12 months
HRQoL
12 months

Collaborators and Investigators

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

Sponsor

University of Aarhus

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)

September 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (ACTUAL)

September 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-1-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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