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

Sponsor

Sykehuset Innlandet HF (Other)

Overall Status

Completed

CT.gov ID

NCT01742442

Collaborator

Oslo University Hospital (Other), Diakonhjemmet Hospital (Other), Vestre Viken Hospital Trust (Other), University of Alberta (Other)

307

Enrollment

Locations

Duration (Months)

102.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer

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 Design

Study Type:

Observational

Actual Enrollment :

307 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Older cancer patients Older cancer patients 70 years or older referred to specialist oncology outpatient clinics

Outcome Measures

Primary Outcome Measures

Prevalence of age related problems [At baseline]
Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life
Physical decline [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

Secondary Outcome Measures

Hospital and nursing home admittance [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 [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 [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 [2 years follow-up]
The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome

Other Outcome Measures

The association between clinical frailty indicators, sarcopenia and inflammatory response [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 [Baseline and 2 years follow-up]
Agreement between physicians evaluation of health status and frailty based on a systematic assessment of frailty indicators

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Lillestrøm	Lørenskog	Norway	N-1478
2	Innlandet Hospital Trust	Brumunddal		Norway
3	Oslo University Hospital Ullevål	Oslo		Norway	0424

Sponsors and Collaborators

Sykehuset Innlandet HF
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