Quality of Life Clinical Trial
Official title:
Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
The study is a randomized study of patients living in four municipalities in Eastern Jutland.
After geriatric assessment half of the patients will be offered a tailor-made intervention in
their homes. The follow-up will last for at least 90 days and include treatment of the
patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The
other half of the patients, the results of the assessment and recommendations will be given
to the patients and their general practitioner.
The primary efficacy variables are accomplishment of planned cancer treatment, reduction of
complications and admissions to hospital and increased quality of life,.
If geriatric assessment and a tailor-made follow-up result in a better quality of life with
less complications and admissions the offer may be extended to a longer period, younger age
groups and other cancer diagnoses.
Cancer of the head and neck (HNC), lung (LC), upper gastrointestinal channel (CUGI) and
colo-rectal cancer (CRC) accounts for approximately 40% of cancer incidence in elderly people
(defined as ≥70 years) in Denmark (DK). The four cancers account for more than 50% of the
annual cancer-related deaths in DK. Incidence and mortality of cancer increases with age.
Comorbidity (simultaneous presence of several medical conditions) are more present in older
cancer patients than in younger This means that older cancer patients are more vulnerable by
physiological, psychological and social means than younger. Older cancer patients frequent
develop side effects of cancer treatment than younger cancer patients.
Comprehensive Geriatric Assessment (CGA), is a comprehensive investigation and assessment of
various aspects of a person's health, carried out by a multidisciplinary team in order to
identify, quantify problems and follow up on the identified problems. CGA comprises
collecting information on comorbidity, polypharmacy, physical, psychological and cognitive
problems, nutritional status and social support. Problems in these areas implies a worse
prognosis in terms of survival, response to treatment and side effects of cancer treatment .
CGA have shown to be able to identify novel health problems in about half of elderly patients
with cancer. It has previously been shown that the focused palliative care of patients with
lung cancer with a focus on optimization of medication and follow up on unresolved problems
increases the quality of life, eases depressive symptoms and increases survival. CGA is shown
to be an effective base for intervention in order to increase the survival of the elderly in
general (with no known cancer), in order to increase the physical and cognitive status, and
to reduce the need for changes in housing facilities. Geriatric intervention based on CGA
called Comprehensive Geriatric Care (CGC).
Frailty is a condition that occurs as a result of declining physiological reserve, causing
vulnerability to health stressors. One way of defining frailty is based on CGA, where
patients are divided into "frail" "vulnerable/pre-frail" and "fit" by performing CGA :
Frail: patients who meet one or more of the following: dependence in Activities of Daily
Living (ADL), severe comorbidity, cognitive dysfunction, depression, malnutrition, or more
than 7 different fixed daily preparations on time for CGA, (multivitamin not included).
Fit patients: independent in ADL and Instrumental Activities of Daily Living (IADL), no or
minimal comorbidity, Cognitively intact and no nutritional problems.
Vulnerable / pre-frail patients: Neither Fit nor frail. Frailty is a potentially reversible
mode. It is known that elderly patients may develop frailty during cancer treatment.
From a previously conducted study of 217 elderly patients with HNC, LC, and CRC CUGI, we know
that a large part of the patients are frail (52%) or vulnerable (35%). Only 13% are fit . But
we do not know the effect of providing geriatric follow-up to this population with regards to
complications of cancer treatment, including the ability to be able accomplish cancer
treatment as planned and the possibility of reducing hospital stay.
A study carried out on patients discharged from the Emergency Department or Geriatric wards,
have shown that it is possible to reduce the admission time by offering CGA related to
admission and add follow-up with the CGC compared to only providing CGA for patients in the
hospital. In the study, hospitalization was reduced by 55% It has not previously been shown
if CGA in an outpatient setting and subsequent Geriatric follow up on the problems identified
can reduce hospitalization time and increase the proportion who accomplish cancer treatment
per protocol in older cancer patients until 1 status examination compared to patients who
only get CGA in the outpatient setting, but do not get geriatric follow-up afterwards.
It's oncology practice at first outpatient attendance to define what type of cancer a patient
must have, this includes both the type of treatment, the aim of treatment (neoadjuvant,
adjuvant, curative or palliative (life-prolonging / palliative)), dose of treatment and
duration of treatment before status examination.
Intervention CGC is an intervention that is tailored to the individual patient based on the
problem areas identified by CGA and the problems that occur within 90 days of enrollment. It
can include home visits, visits to Aarhus University Hospital (AUH) in outpatient settings,
scheduled and on demand and telephone contact. Patients will be followed for 90 days of
enrollment or until reference to specialized palliative care treatment or death. The
geriatric intervention may consist of liquid treatment, blood transfusion, oral or
intravenous antibiotic administration, oxygen therapy, pain management, social intervention,
nutritional intervention and lifeline telephone number The geriatric intervention will be
different from patient to patient. There may be many or few contacts of various kinds. During
the 90 days the number and nature of contacts (telephone / attendance / home visits) will be
recorded as the interventions that are performed will be registered (medication changes,
social work, nutrition efforts and efforts to optimize Physical functioning) Contact between
the oncogeriatric team and the patient can be taken at the initiative of oncogeriatric team,
patient or relatives. The oncogeriatric team can initiate treatment or refer to another
department, if necessary.
Controls For the control group, the result and the recommendations of the CGA, which has been
given to patients regarding. for example medication changes, social intervention (eg.
adaptation of home care), physical optimization for example. training and nutrition
recommendations will be summarized for the patient and with the patient's acceptance sent to
the practitioner. Otherwise, no follow-upis performed in the period by oncogeriatric team.
After 3 months, the intervention group and control Group are tested by CGA and quality of
life questionnaires in order to compare with baseline results and comparing the control group
with the intervention group.
Blinding It is not possible to blind subjects to randomization. Likewise, it is not possible
to blind the geriatric team in charge of the follow-up for the result of the randomization.
The person that test subjects after 3 months is blinded to the randomization. Oncologists do
not get information about randomization.
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