Trial document




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  DRKS00000425

Trial Description

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Title

Presurgical geriatric assessment as a predictor of functional deficits and quality of life in patients undergoing surgery for malignant gastrointestinal tumors

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Trial Acronym

CGA-CI

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URL of the Trial

http:///

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Brief Summary in Lay Language

Study to investigate the influence of geriatric syndromes on short- and intermediate-term quality of life and functional status (frailty and independence) in elderly cancer patients undergoing elective surgery for cancer

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Brief Summary in Scientific Language

Background: Longer life expectancy and lower operative risks have resulted in a large increase in the number of surgical procedures performed in elderly patients. 50% of individuals older than 65 years of age will undergo surgery during their lifetimes.(1) For many, functional declines occur regardless of successful treatment of the medical condition.(2, 3) It is well established that conditions like cancer predict mortality. The addition of simple measures of functional limitation, such as a questionnaire on "Activities of Daily Living" (ADL), significantly refine prediction of morbidity and mortality.(4) Risk stratification is crucial in selecting appropriate treatment options and improving treatment outcomes in the patient population mainly affected by cancer, the elderly. This has further been shown true with regard to pre-surgical assessments and 30 day post-surgical complications within the very recent international prospective study "PACE" which will be discussed in more detail within the protocol as it constitutes pioneer research in this field and warrants the necessity to investigate related topics.(5) Comprehensive geriatric assessment (CGA) provides an overarching method of assessment of elderly patients and can be applied before, during and after treatment. Growing evidence demonstrates that the variables examined in CGA predict morbidity and mortality and uncover problems relevant to cancer care that would otherwise go unrecognized. While still no standardized CGA has been developed, it's increased application can stimulate the development of novel end points for clinical trials that address quality of survival and functional independence in addition to traditional end points, which evaluate disease free and overall survival.(6) Adequate detection of risk factors for functional status decline and the implementation of recommendations to address them are the key factors to the success of prevention programs which have shown to delay the onset of disability.(7, 8)
Objective: This project is designed as a multicenter prospective observational prognostic factor study. All patients diagnosed with a gastrointestinal malignancy considered for a curative operative intervention and meeting all inclusion criteria at participating centers will be enrolled. The proposal will investigate the value of CGA items as prognostic factors with regard to quality of life and independence. The pre- and post-operative assessments incorporate validated, brief and methodically sound geriatric tools together with an assessment of quality of life, operative risk and performance status in 200 patients ≥70 years to identify patients at-risk for functional decline and dependence post tumor surgery. Sample size considerations are based on the primary endpoint 'dependence', defined as any sign of dependence (ADL<100).
Methods: The following assessment tools will be used for the Freiburg Onco-Surgical Assessment of the Elderly: Quality of Life: The EORTC QLQ-C30 is a 30 item, cancer-specific questionnaire designed for patient self-completion. It is organized into five functional scales, three symptom scales, and a global QL scale. The remaining single items assess additional symptoms commonly reported by cancer patients. (9) The prognostic value of single items in cancer patients is increasingly recognized. (10) Performance status: For the Karnofsky Index, each patient is given a score on a linear scale between 0 (dead) and 100 (normally active), summarising their ability to perform daily activities, and the level of assistance they required in order to do so.(11) Mini Mental State Examination (MMSE): Will be used as screening instrument for assessing cognitive function.(12) Timed Up-and-Go: A brief assessment of gait and balance that has been frequently used in the geriatric setting.(13) Activities of Daily Living (ADL-Barthel Index) and Instrumental Activities of Daily Living (13): ADL - according to the Hamburger Manual: A quick and reliable assessment of a person's mobility and ability to perform daily self-care tasks. (14, 15) IADL scale measures eight complex activities related to independent functioning. Both have shown a high prognostic value in certain cancer entities.(6, 13, 16) Comorbidities: Distinct additional clinical entities that exist or may occur during the clinical course of a patient with a primary (index) disease. The Charlson Comorbidity Index (CCI) is the most frequently used in oncology. It has a good reliability, excellent correlation with mortality and progression-free survival outcomes. (17) Mini Nutritional Assessment : The test is able to classify an elderly person as well-nourished, at risk for malnutrition and malnourished.(18) Operative Risk: POSSUM (The Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity): The scoring system was developed to predict 30-day mortality and morbidity rates. It assesses 12 physiological measures and six operative measures.(19) Resilience Scale (11 item version): Resilience is defined as the capability of person to maintain its functions and integrity in the face of internal and external changes and to degrade gracefully when it must. Recently, studies have been published showing resilience to be an important psychological predictor of QoL and coping in cancer patients. (20-22)
Summary: Deconditioning and impaired functional status resulting in dependence and diminished QOL is a serious problem in elderly patients undergoing surgical procedures for malignancies. It is our responsibility to ensure that we provide the growing number of elderly cancer patients with the greatest opportunities to return to their preoperative functional status and good quality of life. The Departments of the University Hospital Freiburg participating in this trial are known for actively pursuing several research and interventional onco-geriatric projects focusing on optimizing treatment and quality of life for elderly patients. This is the first approach to investigate the influence of geriatric syndromes on short- and intermediate-term quality of life and functional status (frailty and independence) in elderly cancer patients undergoing elective surgery for cancer in Europe.

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Organizational Data

  •   DRKS00000425
  •   2010/07/12
  •   2008/03/22
  •   yes
  •   Approved
  •   372/07, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001481  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C15-C26 -  Malignant neoplasms of digestive organs
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Interventions/Observational Groups

  •   /
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Dependence , defined as Activities of Daily Living (ADL) ≤ 95 (ADL = Barthel Index), 6 months after surgery

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/08/19
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with malignant gastrointestinal tumors with elective surgical intervention in curative intent

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Exclusion Criteria

palliative intervention, emergency intervention, impaired mental status with inability to fill out questionnaire and to obey simple demands, inability to communicate in German language

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Addresses

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    • , Ärztlicher Direktor, Universitätsklinikum Freiburg / Chirurgische Universitätsklinik - Abteilung Allgemein- und Viszeralchirurgie
    • Mr.  Prof. Dr. Dr. h.c.  Ulrich  Hopt 
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg / Chirurgische Universitätsklinik - Abteilung Allgemein- und Viszeralchirurgie
    • Mr.  PD Dr.  Peter  Baier 
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg / Chirurgische Universitätsklinik - Abtlg. Allgemein- und Viszeralchirurgie
    • Mr.  Klaus  Brummel 
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstraße 32
    • 53113  Bonn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/19
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Trial Publications, Results and other Documents

  •   Baier, P. et al (2016) Independence and health related quality of life in 200 onco-geriatric surgical patients within 6 months of follow-up: Who is at risk to lose?
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* This entry means the parameter is not applicable or has not been set.