Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

— AGE CRC  

Official title:

Advanced Geriatric Evaluation in Predicting Health Related Quality of Life in Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443816
• Other study ID #: NL6152310017
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 6, 2021

Study information

• Verified date: September 2021
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 Activity 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, tumor characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood sampling will be collected. At three, six and twelve months after diagnosis, EORTC QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and disability free survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age = 70 years

• Histologically proven non-metastatic colorectal cancer

• Signed informed consent

Exclusion Criteria:

• - Emergency surgical procedures

• Insufficient understanding of the Dutch language

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Netherlands	Meander medical center	Amersfoort
Netherlands	Tergooi hospital	Hilversum
Netherlands	St Antonius Hospital	Nieuwegein
Netherlands	Rivierenland ziekenhuis	Tiel
Netherlands	Diakonessenhuis	Utrecht
Netherlands	UMCU	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of health related quality of life (HRQL)	Change in EORTC QLQ-C30	12 months
Secondary	Loss of health related quality of life (HRQL)	Change in EORTC QLQ-C30	3 months
Secondary	Postoperative complications	Complication after surgery	30 days
Secondary	Disability	EQ-5D	12 months