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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742442
• Other study ID #: E12224
• Secondary ID: 2012/104 C
• Status: Completed
• First received: November 26, 2012
• Last updated: April 17, 2018
• Start date: January 2013
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Norway	Innlandet Hospital Trust	Brumunddal
Norway	Akershus University Hospital	Lillestrøm	Lørenskog
Norway	Oslo University Hospital Ullevål	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Diakonhjemmet Hospital, Oslo University Hospital, University of Alberta, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1. — View Citation

Kristjansson SR, Nesbakken A, Jordhøy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The association between clinical frailty indicators, sarcopenia and inflammatory response	Association between clinical frailty indicators, sarcopenia and inflammatory response	Baseline and 2 years follow-up
Other	The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators	Agreement between physicians evaluation of health status and frailty based on a systematic assessment of frailty indicators	Baseline and 2 years follow-up
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	survival	The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome	2 years follow-up