Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery (AGE CRC)

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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Meander Medical Center
  • Hilversum, Netherlands
    • Tergooi Hospital
  • Nieuwegein, Netherlands
    • St Antonius hospital
  • Tiel, Netherlands
    • Rivierenland Ziekenhuis
  • Utrecht, Netherlands
    • Diakonessenhuis
  • Utrecht, Netherlands
    • UMCU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

aged ≥ 70 years with a new diagnosis of non-metastatic CRC

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of health related quality of life (HRQL)	Change in EORTC QLQ-C30	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Publications and helpful links

General Publications

• van der Vlies E, Vernooij LM, Hamaker ME, van der Velden AMT, Smits M, Intven MPW, van Dodewaard JM, Takkenberg M, Vink GR, Smits AB, Bos WJW, van Dongen EPA, Los M, Noordzij PG. Frailty and health related quality of life three months after non-metastatic colorectal cancer diagnosis in older patients: A multi-centre prospective observational study. J Geriatr Oncol. 2022 Jan;13(1):74-81. doi: 10.1016/j.jgo.2021.08.005. Epub 2021 Aug 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): July 6, 2021
• Study Completion (ACTUAL): July 6, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NL6152310017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No