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Cancer in the Elderly: Prevalence and Impact of Age Related Problems

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ClinicalTrials.gov Identifier: NCT01742442
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Oslo University Hospital
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
University of Alberta
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Tracking Information
First Submitted Date November 26, 2012
First Posted Date December 5, 2012
Last Update Posted Date April 19, 2018
Study Start Date January 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2014)
  • Prevalence of age related problems [ Time Frame: At baseline ]
    Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life
  • Physical decline [ Time Frame: Follow-up ]
    Physical decline during follow-up, as measured by the EORTC QLQ-C30 questionnaire. We will investigate the predictive value of frailty (measured by clinical indicators), sarcopenia and inflammatory response on this outcome. Primary endpoint is defined as 2 months of follow-up
Original Primary Outcome Measures
 (submitted: December 3, 2012)
Prevalence of age related problems [ Time Frame: At baseline ]
Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2014)
  • Hospital and nursing home admittance [ Time Frame: 2-4 months and 2 years follow-up ]
    The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
  • Quality of life [ Time Frame: 2 - 4 months and 2 years follow-up ]
    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
  • Treatment toxicity [ Time Frame: 2-4months and up to 2 years ]
    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome "treatment toxicity" defined in terms of any adverse event requiring hospital admission and haematological toxicity (grade 3-4 cytopenia). Toxicity during the first course of chemotherapy (2-3 weeks), during 3-4 courses (2-3 months) and for the whole follow-up. i.e. up to 2 years will be investigated
  • survival [ Time Frame: 2 years follow-up ]
    The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome
Original Secondary Outcome Measures
 (submitted: December 3, 2012)
  • Hospital and nursing home admittance [ Time Frame: 2-4 months and 2 years follow-up ]
    The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
  • Quality of life [ Time Frame: 2 years follow-up ]
    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
  • Treatment toxicity [ Time Frame: up to 2 years ]
    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome "treatment toxicity" defined in terms of any adverse event requiring hospital admission and haematological toxicity (grade 3-4 cytopenia). Toxicity during the first course of chemotherapy (2-3 weeks), during 3-4 courses (2-3 months) and for the whole follow-up. i.e. up to 2 years will be investigated
  • survival [ Time Frame: 2 years follow-up ]
    The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2018)
  • The association between clinical frailty indicators, sarcopenia and inflammatory response [ Time Frame: Baseline and 2 years follow-up ]
    Association between clinical frailty indicators, sarcopenia and inflammatory response
  • The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators [ Time Frame: Baseline and 2 years follow-up ]
    Agreement between physicians evaluation of health status and frailty based on a systematic assessment of frailty indicators
Original Other Pre-specified Outcome Measures
 (submitted: December 3, 2012)
  • The association between clinical frailty indicators, sarcopenia and inflammatory response [ Time Frame: Baseline and 2 years follow-up ]
  • The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators [ Time Frame: Baseline and 2 years follow-up ]
 
Descriptive Information
Brief Title Cancer in the Elderly: Prevalence and Impact of Age Related Problems
Official Title Cancer in the Elderly: Prevalence and Impact of Age Related Problems. A Prospective Observational Study
Brief Summary About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric problems may influence the course of cancer and its treatment. The present study is a prospective observational study. Age related problems will be assessed by clinical frailty indicators covering areas that are recommended in geriatric oncology. The aim is to describe the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of age, to investigate the predictive/prognostic impact of these indicators on cancer and treatment related morbidity and mortality, and to investigate the association between clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI), Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300 with 30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration with several external national and international centres
Detailed Description

The proportion of elderly cancer patients is high and is likely to increase due to an increasing cancer incidence and an aging population. The prevalence and impact of age related problems are, however, poorly documented, and elderly patients may therefore be subjects to under-treatment and arbitrary modifications of treatment regimens. In order to improve clinical practice, precise identification of patients with increased vulnerability and risk of adverse outcomes is paramount.

In the present study, eligible patients will be identified by referral to oncology services at one of the participating cancer units. After consent, the baseline registrations will be performed including relevant medical and sociodemographic data, and quality of life. Age related problems will be assessed by clinical indicators covering comorbidity, medication, emotional, physical and cognitive function and nutritional status. Muscle mass will be quantified by analyses of diagnostic CT scans and a biobank will be established for the analyses of inflammatory markers. Upon inclusion, the patients' physician will be asked to rate the patients as fit, frail or intermediate according to the physicians' subjective judgement. The patients will be followed with assessments of quality of life, emotional function and nutritional status (self-report), cognitive and physical function (self-report and performance tests), muscle mass (diagnostic CT scans when available) and inflammatory markers (biobank). Follow up data will also include registry data (hospital records, primary health care registries, The Norwegian Patient Registry, The Norwegian Cancer Registry and the Norwegian Cause of Death registry). We will describe the prevalence of age related problems, investigate the relation between clinical frailty indicators, sarcopenia, inflammatory response and the physicians' subjective evaluation of the patients' health status. The predictive/prognostic impact of frailty indicators on the patients' self-reported physical function and quality of life, hospital and nursing home admittance, treatment toxicity and survival will also be investigated

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples (serum and EDTA blood) for analysis of inflammatory markers. Dependent on the study results and results from other studies that may emerge during the study conduct, analyses of other markers of ageing may also be conducted
Sampling Method Probability Sample
Study Population Consequetive patients referred to a specialist outpatient clinic for medical cancer treatment
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts Older cancer patients
Older cancer patients 70 years or older referred to specialist oncology outpatient clinics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 17, 2018)
307
Original Estimated Enrollment
 (submitted: December 3, 2012)
400
Actual Study Completion Date April 2017
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age >= 70 years
  • histologically/cytologically verified cancer disease
  • referred to specialist oncology service
  • no former chemotherapy for actual status (new cancer diagnosis no former or chemotherapy for metastatic disease)
  • subject to medical oncological treatment that may be initiated and administered at the hospital trust the patient is referred to
  • able to provide written consent
  • fluent in Norwegian (orally and written)

Exclusion Criteria:

- lymphomas and haematological malignancies

Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01742442
Other Study ID Numbers E12224
2012/104 C ( Other Identifier: Regional Ethical Review Board HSO, Norway )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sykehuset Innlandet HF
Study Sponsor Sykehuset Innlandet HF
Collaborators
  • Oslo University Hospital
  • Diakonhjemmet Hospital
  • Vestre Viken Hospital Trust
  • University of Alberta
Investigators
Principal Investigator: Marit S Jordhøy, MD, PhD Sykehuset Innlandet and Oslo University Hospital
Principal Investigator: Siri Kristjansson, MD, PhD Diakonhjemmet Hospital
PRS Account Sykehuset Innlandet HF
Verification Date September 2017