Cancer in the Elderly: Prevalence and Impact of Age Related Problems
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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 will be recruited at outpatient cancer services, Innlandet Hospital HF (SI), Vestre Viken HF and Oslo University Hospital.Estimated sample size is 400 with 18 to 24 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 |
- 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
- 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 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: 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
- 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: | 400 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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 (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' 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 |
Consequetive patients referred to a specialist outpatient clinic for medical cancer treatment
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| Contact: Marit S Jordhøy, MD, PhD | +47 91857831 | marit.jordhoy@sykehuset-innlandet.no |
| Contact: Siri Kristjansson, PhD | +4790787614 | sirikristjansson@gmail.com |
| Norway | |
| Vestre Viken HF Bærum Hospital | Not yet recruiting |
| Bærum, Rud, Norway, 1309 | |
| Contact: Line Fronth, MD 95005568 ext +47 line.fronth@vestreviken.no | |
| Principal Investigator: Line Fronth, MD | |
| 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 | |
| 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 | |
| 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: | May 30, 2013 |
| 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 June 17, 2013