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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Older cancer patients<br>Older cancer patients 70 years or older referred to specialist oncology outpatient clinics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of age related problems | Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life | At baseline | 
| Physical decline | 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 | Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital and nursing home admittance | The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome | 2-4 months and 2 years follow-up | 
| Quality of life | The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome | 2 - 4 months and 2 years follow-up | 
| Treatment toxicity | 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 | 2-4months and up to 2 years | 
| survival | The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome | 2 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, elderly OR older, chemotherapy, geriatric assessment