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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sykehuset Innlandet HF
Sponsor:
Collaborators:
Oslo University Hospital
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
University of Alberta
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT01742442
First received: November 26, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer in the Elderly: Prevalence and Impact of Age Related Problems. A Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Prevalence of age related problems [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life

  • Physical decline [ Time Frame: Follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2-4 months and 2 years follow-up ] [ Designated as safety issue: No ]
    The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome

  • Quality of life [ Time Frame: 2 - 4 months and 2 years follow-up ] [ Designated as safety issue: No ]
    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome

  • Treatment toxicity [ Time Frame: 2-4months and up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 years follow-up ] [ Designated as safety issue: No ]
  • The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators [ Time Frame: Baseline and 2 years follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples (serum and EDTA blood) for analysis of inflammatory markers. Dependent on the study results and results from other studies that may emerge during the study conduct, analyses of other markers of ageing may also be conducted


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Older cancer patients
Older cancer patients 70 years or older referred to specialist oncology outpatient clinics

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consequetive patients referred to a specialist outpatient clinic for medical cancer treatment

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742442

Contacts
Contact: Marit S Jordhøy, MD, PhD +47 91857831 marit.jordhoy@sykehuset-innlandet.no
Contact: Siri Kristjansson, PhD +4790787614 sirikristjansson@gmail.com

Locations
Norway
Innlandet Hospital Trust Recruiting
Brumunddal, Norway
Contact: Marit Jordhøy, PhD MD    91857831 ext 47    mjorhoy@gmail.com   
Principal Investigator: Marit S Jordhøy, PhD MD         
Sub-Investigator: Geir Selbæk, MD PhD         
Sub-Investigator: Jon Elling Whist, MD, prof em         
Sub-Investigator: Sverre Bergh, MD, PhD         
Akershus University Hospital Recruiting
Lørenskog, Norway, N-1478
Contact: Olav E Yri, MD, PhD    97680651 ext +47    olav.erich.yri@ahus.no   
Principal Investigator: Olav E Yri, MD, PhD         
Oslo University Hospital Ullevål Recruiting
Oslo, Norway, 0424
Contact: Morten Brændengen, MD, PhD       UXBRNM@ous-hf.no   
Principal Investigator: Morten Brændengen, MD PhD         
Sub-Investigator: Torgeir Bruun Wyller, MD, Prof         
Sub-Investigator: Marianne Jensen Hjermstad, MD PhD         
Sub-Investigator: Nina Aass, MD Prof         
Sub-Investigator: Asta Bye, PhD         
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
  More Information

Publications:
Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT01742442     History of Changes
Other Study ID Numbers: E12224, 2012/104 C
Study First Received: November 26, 2012
Last Updated: September 8, 2014
Health Authority: Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Sykehuset Innlandet HF:
Cancer
elderly OR older
chemotherapy
geriatric assessment

ClinicalTrials.gov processed this record on September 16, 2014