Clinical trial NCT01742442: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
elderly OR older
chemotherapy
geriatric assessment
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Diakonhjemmet Hospital
name: Vestre Viken Hospital Trust
name: University of Alberta
First posted: 2012-12-05
Enrollment: 307
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consequetive patients referred to a specialist outpatient clinic for medical cancer treatment

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

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

Primary outcomes:
measure: Prevalence of age related problems
timeFrame: At baseline
measure: Physical decline
timeFrame: Follow-up
Secondary outcomes:
measure: Hospital and nursing home admittance
timeFrame: 2-4 months and 2 years follow-up
measure: Quality of life
timeFrame: 2 - 4 months and 2 years follow-up
measure: Treatment toxicity
timeFrame: 2-4months and up to 2 years
measure: survival
timeFrame: 2 years follow-up
Other outcomes:
measure: The association between clinical frailty indicators, sarcopenia and inflammatory response
timeFrame: Baseline and 2 years follow-up
measure: The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators
timeFrame: Baseline and 2 years follow-up
Locations:
city: Lillestrøm
country: Norway
facility: Akershus University Hospital
state: Lørenskog
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevål
Study officials:
affiliation: Sykehuset Innlandet and Oslo University Hospital
name: Marit S Jordhøy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diakonhjemmet Hospital
name: Siri Kristjansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kristjansson SR, Nesbakken A, Jordhoy MS, Skovlund E, Audisio RA, Johannessen HO, Bakka A, Wyller TB. Comprehensive geriatric assessment can predict complications in elderly patients after elective surgery for colorectal cancer: a prospective observational cohort study. Crit Rev Oncol Hematol. 2010 Dec;76(3):208-17. doi: 10.1016/j.critrevonc.2009.11.002. Epub 2009 Dec 14.
citation: Kirkhus L, Harneshaug M, Saltyte Benth J, Gronberg BH, Rostoft S, Bergh S, Hjermstad MJ, Selbaek G, Wyller TB, Kirkevold O, Borza T, Saltvedt I, Jordhoy MS. Modifiable factors affecting older patients' quality of life and physical function during cancer treatment. J Geriatr Oncol. 2019 Nov;10(6):904-912. doi: 10.1016/j.jgo.2019.08.001. Epub 2019 Aug 21.