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CancerNCT01742442

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

An observational study of Cancer, run by Sykehuset Innlandet HF at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Cancer
How many people
307 participants
Where
3 sitesNorway
Study dates
Jan 2013to Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • lymphomas and haematological malignancies

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Innlandet Hospital Trust

    Brumunddal

  • Akershus University Hospital

    Lillestrøm, Lørenskog, N-1478

  • Oslo University Hospital Ullevål

    Oslo, 0424

Other trials in Norway

About this study

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

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

Read the 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

Conditions
Cancer
Keywords
Cancer, elderly OR older, chemotherapy, geriatric assessment
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01742442
Study groupRoleWhat they receive
Older cancer patientsOlder cancer patients 70 years or older referred to specialist oncology outpatient clinics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At baseline

  2. 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

    Measured: Follow-up

Secondary outcomes (4)

  1. Hospital and nursing home admittance

    The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome

    Measured: 2-4 months and 2 years follow-up

  2. Quality of life

    The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome

    Measured: 2 - 4 months and 2 years follow-up

  3. 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

    Measured: 2-4months and up to 2 years

  4. survival

    The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome

    Measured: 2 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2015
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01742442
Sponsor's protocol ID
E12224
Other IDs
2012/104 C
Status last verified
Sep 2017
First submitted
26 Nov 2012
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21810685

  • 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.

    PubMed 20005123

  • 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.

    PubMed 31444088

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Sykehuset Innlandet HF at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of age related problems (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01742442, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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