1. To determine the predictive value of frailty characteristics for loss of HRQL in elderly patients with non-metastatic CRC.2. To develop an AGE-CRC score, a prediction model for loss of HRQL in elderly patients with CRC based on comorbidity, risk…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is a loss of HRQL * 10 points(EORTC-QLQ-C30) at 12 months
after CRC diagnosis.
Secondary outcome
Secondary endpoints are: HRQL after 3 and 6 months (EORTC-QLQ-C30/CR29),
disability free survival after 3, 6 and 12 months (EQ-5D), postoperative
complications during hospitalisation, number of hospital (re)admissions and
outpatient visits during the study period, number of unexpected intensive care
admissions, 30 days and 1 year mortality.
Background summary
Colorectal cancer (CRC) disproportionately affects patients aged 70 years and
older. Surgery is the main treatment modality for CRC, but is associated with
increased risk of postoperative morbidity, disability and loss of health
related quality of life (HRQL). Frailty is an age related state of functional
decline and considered to be an important risk factor for adverse outcome in
geriatric oncology. Risk models for adverse outcome may be used for treatment
decisions in the elderly, but are often not designed to predict patient related
outcome measures and do not include frailty characteristics.
Study objective
1. To determine the predictive value of frailty characteristics for loss of
HRQL in elderly patients with non-metastatic CRC.
2. To develop an AGE-CRC score, a prediction model for loss of HRQL in elderly
patients with CRC based on comorbidity, risk factors and frailty.
Study design
Multicentre, prospective, observational cohort study with a follow up time of
one year. After initial diagnosis of CRC subjects will be screened for frailty
using validated questionnaires, physical tests and non-invasive measurements.
Frailty characteristics and HRQL are determined by Geriatric 8 (G8), Hospital
Anxiety and Depression Scale(HADS), Euroqol- 5 dimensional (EQ-5D), Lawton
Instrumental Activities of Daily Living scale(IADL), Mini Nutrition Assessment
(MNA), 6 Item Cognitive Impairment Test (6-CIT), Identification of Seniors At
Risk * Hospitalized Patients(ISAR-HP) and the EORTC-QLQ-C30/CR29 (HRQL in CRC
patients). Physical tests include the Timed to Get Up (TUG) test and the hand
grip strength test. Furthermore, the non-invasive measurements consist of a
sarcopenia analysis using an existing CT/MRI scan and measurement of Advanced
Glycation Endproducts (AGE reader).
Additional patients characteristics including medication use, medical history
and laboratory results of preoperative routine blood sampling will be
collected. At three, six and twelve months after surgery or diagnosis, EORTC
QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and
disability free survival.
Study burden and risks
Frailty screening will be performed in all study patients with a new diagnosis
of non-metastatic CRC and will approximately take 40 minutes per patient. This
is an observational study, there are no expected risks associated with frailty
screening. Participation in this study will not conflict with standard care and
will not delay diagnosis or treatment. There is no individual benefit for the
participating subjects. Currently little is known about the relation between
frailty and HRQL after CRC surgery/diagnosis. No risks are expected as the
subjects will be treated similar to patients who dot no participate. If this
study shows that a risk model including frailty characteristics is predictive
for loss of HRQL after CRC surgery, implementation of this model (after
validation) in standard care should be considered.
Koekoekslaan 1 Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1 Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
Age * 70 years
Histologically proven non-metastatic colorectal cancer
Exclusion criteria
Emergency surgery
Insufficient understanding of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61523.100.17 |