Fatigue and Quality of Life in Patients With Neuroendocrine Neoplasia
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
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8200
- Recruiting
- Gitte Dam
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Contact:
- Gitte Dam
- Phone Number: 31562547
- Email: gitdam@rm.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: all newly diagnosed NET and NEC patietns Exclusion Criteria:None
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Study Plan
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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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