Cancer Clinical Trial
Official title:
Cancer in the Elderly: Prevalence and Impact of Age Related Problems. A Prospective Observational Study
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
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
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