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OpenTrials
Completed

NCT Number: NCT04443816

Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Meander medical center, Amersfoort, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Loss of health related quality of life (HRQL)

    Time frame: 12 months

    Change in EORTC QLQ-C30

Secondary outcomes

  1. Loss of health related quality of life (HRQL)

    Time frame: 3 months

    Change in EORTC QLQ-C30

  2. Postoperative complications

    Time frame: 30 days

    Complication after surgery

  3. Disability

    Time frame: 12 months

    EQ-5D

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: AGE CRC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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