Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04557137 |
| Other study ID # |
1-10-72-1-20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
September 2020 |
| Source |
University of Aarhus |
| Contact |
Gitte Dam |
| Phone |
31562547 |
| Email |
gitdam[@]rm.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
