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

NCT01742442 | Completed

• 2 other identifiers: E122242012/104 C
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 3

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

Conditions

Cancer

Keywords

Cancer; elderly OR older; chemotherapy; geriatric assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Hospital and nursing home admittance

  2-4 months and 2 years follow-up

• Quality of life

  2 - 4 months and 2 years follow-up

• Treatment toxicity

  2-4months and up to 2 years

• survival

  2 years follow-up

Other Outcomes (2)

• The association between clinical frailty indicators, sarcopenia and inflammatory response

  Baseline and 2 years follow-up

• The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators

  Baseline and 2 years follow-up

Study Arms (1)

Older cancer patients

Older cancer patients 70 years or older referred to specialist oncology outpatient clinics

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• \- lymphomas and haematological malignancies

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Oslo University Hospital: collaborator
• Diakonhjemmet Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• University of Alberta: collaborator

Study Sites (3)

Akershus University Hospital

Lillestrøm, Lørenskog, N-1478, Norway

Location

Innlandet Hospital Trust

Brumunddal, Norway

Location

Oslo University Hospital Ullevål

Oslo, 0424, Norway

Location

Related Publications (3)

• 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.

  PMID: 21810685 BACKGROUND

• 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.

  PMID: 20005123 BACKGROUND

• 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.

  PMID: 31444088 DERIVED

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marit S Jordhøy, MD, PhD

  Sykehuset Innlandet and Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Siri Kristjansson, MD, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 5, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2017-09

Locations

NO (3)