The aim of this project is to maintain quality of life and improve cancer related outcome by preventing therapy-related toxicity (and ensuing unplanned hospital admission and /or discontinuation of chemotherapy) in cancer patients treated with…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Health condition
kankerbehandeling bij oudere patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Less unexpected hospitalizations
Secondary outcome
1. Patiënt reported outcome measures (PROM) about intensive monitoring
2. Hospital replaced care in transmural collaboration
3. Implementation of a web-based platform for intensive monitoring of treatment
related adverse effects
4. Knowledge on possible differences between Dutch regions and community versus
university hospital
5. Comparison of data from Easycare-Tos with two
screeningsinstrument used in older cancer patients (G8 and GFI) and data from a
limited geriatric assessment (IADL, GDS en MNA)
Background summary
The number of patients aged over 65 years diagnosed with cancer is increasing
over the last years. In the year 2000, cancer was diagnosed in the Netherlands
in about 69,000 patients, including 40,000 patients aged over 65 years. In 2015
an incidence of 95,000 patients is expected, including over 58,000 patients
aged over 65 years (1).
This large number of senior cancer patients will more and more cause a strain
on our health care system and urge for collaboration between home care
providers and hospitals.
The majority of older cancer patients present in community hospitals. There
seems to be an underrepresentation of older cancer patients in University
hospitals compared to large community hospitals. In 2012 about 10% of new
patients in the department of medical oncology of the Radboud University
Medical Center (RUMC) is aged over 65 years, whereas in the Medisch Spectrum
Twente (MST) this percentage is about 45%. Of note, the percentage of 65+
patients in the departments of surgery and urology are expected to be higher
than this 10% and 45% respectively. Besides this underrepresentation in
university medical centers, it is highly likely that also other patients
characteristics are different between university hospitals and community
hospitals. In a current collaborative project assessing preferences for
treatment in MST and RUMC, patients in the RUMC had a higher the mean education
level than in MST (2). University hospitals are more focused on research then
community hospitals.
Because of all the above, we regard cooperation between university hospitals
and community hospitals requisite in innovative projects regarding cancer in
the elderly, and we urge for collaboration with GPs.
Systemic therapy (cytostatic and/or targeted treatment) can be beneficial to
cancer patients, regardless of age, however, older patients are at risk for
treatment-related toxicity. Treatment related side-effects and unplanned
hospital admissions (UHA) have a major impact on quality of life, threatening
independence (3,4). Treatment related side-effects often lead to dose
reductions, and in older patients even low grade toxicities (grade I/II) led
frequently to treatment modifications (5).
Geriatric assessments are increasingly advocated for use in oncology. A
Complete Geriatric Assessment (CGA) is defined as a multidisciplinary
evaluation in which multiple problems of older people are uncovered, described
and if possible explained, and in which the resources and strength of the
person are catalogued and a coordinated plan is developed to focus
interventions on the individual persons problems (6). In general, the positive
health effects of GCA have been established, for example in prevention of
functional decline and (re)hospitalisations (7) but in oncology data are still
scarse. In geriatric medicine, a GCA is discussed in a multidisciplinary team
and this leads to individual treatment goals and individual intervention plans
are made. Until now in oncology, GCA is mostly used for discovering unknown
health problems, and for prediction of survival or tolerance for chemotherapy,
without making individual treatment goals or intervention plans (8). However,
also in regular oncology practice data derived from a GCA could lead to
personalized interventions aimed at improving quality of life and prevention of
toxicity.
Despite all these arguments underscoring the relevance of performing a CGA
there are still barriers to implement a CGA in common practice. These arguments
encompass the following issues.
* GCA data on tolerance for treatment are not consistent, and several studies
in oncology reveal different tests to be most useful of different outcomes
measures. For example, in Dutch lung cancer patients aged * 70 years receiving
first line palliative chemotherapy, CGA appeared of limited value for
predicting toxicity or finishing all cycles of chemotherapy. Patients with
worse scores on the Geriatric Depression Score-15 were more likely to
experience neuropsychiatric toxicity. Patients with better scores on ADL
(activities of daily living) or IADL (instrumental activities of daily living)
were more likely to finish all scheduled chemotherapy cycles (9). Worse scores
on GDS and Groningen Frailty Indicator were associated with reduced survival,
as was the classical Performance Score. In another Dutch study evaluating 70+
patients with different primary tumors treated with chemotherapy found that
lower scores for tests for nutrition (Mini Nutritional Assessment, MNA ) and
cognition (Mini Mental State Examination, MMSE) were associated with less
cycles of chemotherapy. In addition, inferior scores on MNA and MMSE were
associated with an increased mortality after the start of chemotherapy (10). In
a French study including similar patients (70+, different tumor types,
chemotherapy) MNA and poor mobility predicted early death (11). Another French
study in 75+ patients receiving first line chemotherapy for metastatic
colorectal cancer, MMSE and IADL were predictive for grade III/IV toxicity and
deviant scores on GDS and MMSE were associated with unexpected hospitalization,
which occurred in 44% of patients (12).
* A CGA is time consuming and this aspect appeared both for patients and
family, as well as for physicians an important reason for not participating in
a Dutch study regarding CGA in patients with metastatic breast cancer receiving
first line chemotherapy (13). Therefore, a two step approach has been
advocated, using a screening method followed by a CGA in those patients scoring
impairments on the screening tool. Several screening tools have been used, like
the Vulnerable Eldery Survey-13 (VES-3), the Geriatric 8 (G8) and the Groningen
Frailty Indicator (GFI), but until no final judgment can be made whether these
instruments have sufficient discriminative power to select patients for further
assessment (14). The largest study on screening followed by assessment in
cancer patients included 1967 Belgian patients used the G8 screening tool. Only
29% of patients appeared * fit* and did not require a CGA (15). Using the GFI
63% appeared fit in Dutch cancer patients scheduled for chemotherapy (10)
If the time consuming aspect of a geriatric assessment is a major obstacle for
daily oncology practice, the question is how to reduce this. One option is to
use already available information at the General Practitioner (GP) practice.
Recently the Easycare-Two-step Olders person screening (Easycare-TOS) was
developed in a collaborative project of the departments of Geriatrics and
General Practice at the RUMC, and appeared an indentification instrument for
frailty in primary care (16). This Easycare-TOS was developed because all the
existing screening tools don*t implement information that is already available
at the GP including tacit (implicit) knowledge and other potential available
information of primary health care workers. The first step in the Easycare-TOS
instrument is a list of 14 questions answered by the GP, and after filling in
the GP judges whether the patient is * not frail*, *frail* or *unclear*. All
patients scoring *frail* or *unclear* proceed to the second step with a
structured assessment. So, this Easycare-TOS has the advantages that the
professional*s appraisal is important and the care context of the patient in
involved (16). Involvement of these two could be very relevant as the majority
of older cancer patients suffer from co-morbidity and often patients are
involved in several multi agency healthcare systems (*ketenzorg*), for example
for COPD, diabetes and heart failure, and unfortunately the communications
between all those systems is often far from ideal.
In the Radboud UMC, all older patients (>70years) who started chemotherapy in
period May 2011-May 2013 were reviewed, and an 36% incidence of UHA was
observed (17). UHA occurred despite a pretreatment-assessment (using
Easycare-TOS) provided to all patients with interventions taken for unmet needs
if necessary and despite follow up by a oncology nurse in the first week of
treatment by phone calls. Most UHA were treatment related (83%), occurred in
first treatment cycles (47%) and markedly, after patient*s delayed toxicity
reporting (50%). Frequently complaints existed already for over 48 hours
without early report to their oncologist, despite explicit pre-treatment
instructions by a geriatric oncology nurse specialist to do so. Although the
majority of patients recovered and were discharged back home (93%), UHA led to
treatment modification in 80%; 37% discontinuing without alternative systemic
therapy being started. Further analyses showed a mean day of admission on day 8
after chemotherapy and the two most frequent reasons for admission were
dehydration due to gastro-intestinal adverse events and fever.
The finding that patients do not report side effects timely and reliably was
previously demonstrated in a study in which patients receiving chemotherapy
used a Therapy-Related Symptom Checklist (TRSC) during the first 7 days of
treatment (immediate) and at their next visit to the hospital (delayed). It
appeared that patients reported less symptoms and less severe symptoms when
they reported at the next hospital visit (18). This underreporting of toxicity
leads to an unwanted lack of reductions and chance of even more serious
toxicity after the next cycle of chemotherapy.
By monitoring toxicity early and taking supportive care measurements before
severe (sequels of) toxicity develop, UHA and its consequences on both QoL and
further treatment might be prevented (3,4). However, numbers of older cancer
patients will increase and the use of internet and/or social media might be an
effective way to support medical staff. In a Norwegian randomized trial in
patients with leukemia or lymphoma, the use of a computer assisted interactive
tailored patient assessment tool resulted in increased symptom reporting but
reduced distress due to these symptoms and reduced need for symptom management
support (19)
Dutch society will digitalize rapidly: in 2009 about 1/3rd of 65-75 year old
never used a personal computer, but this number was only 13% in ages 55-65
years old; in 2013 already more than 50% of 65-75 year old use the internet
regularly. In 2012 about one third of persons aged 75+ used internet (20) .
Reshape developed *Hereismydata **; a platform where patients can keep their
personal health record together with a connectivity tool in which they can
upload any kind of data to health care professionals of their choice. This
tool can be used in primary health care as well in hospital care and provides
tools for monitoring patients by their carers. A specific questionnaire will
be developed focusing on the most frequent chemotherapy-related side effects
leading to UHA (for example for diarrhea, dehydration and fever).
Study objective
The aim of this project is to maintain quality of life and improve cancer
related outcome by preventing therapy-related toxicity (and ensuing unplanned
hospital admission and /or discontinuation of chemotherapy) in cancer patients
treated with systemic therapy by the following procedures.
1. Integration of care/ transmural collaboration
1.1. Participation of GP in the assessment of cancer patients starting
treatment by using the first step of Easycare-TOS
1.2. Patients presenting in the MST will be visited by the oncology nurse at
home. At this visit other caregivers (POH, district nurse, home care) will be
invited for a round table, for explanation and education about side effects,
and care needs will be assessed. If other caregivers are unable to attend, they
will be actively informed by telephone before start of treatment. For patients
from the UMCN there will be no home visits, but all other caregivers are
actively informed before treatment starts.
1.3. Frequent contact of hospital-based specialized oncology nurse with POH/
home care/ district nurse
1.4. Home visits of GP/POH/district nurse to manage toxicity and/or evaluation
/preparation for next treatment cycle in close contact with hospital team.
2. Integrating *Hereismydata ** in daily care to monitor treatment-related
toxicity using a short questionnaire to be filled in by the patient on a
2-daily basis in the first cycle of treatment and on demand there-after; in
case the questionnaire needs follow up or no questionnaire is received the
hospital nurse will either contact the patient or POH/ homecare/district nurse
for further actions to assist in a structured transfer of care and
responsibilities a (online) form will be developed and tested
In patients that are no internet users, their children or other care givers
will are asked to fill in these data.
3. Education of home care providers to provide them with tools to adequately
intervene / counsel oncology patients by developing a teaching module in
collaboration with the HAN/ dr. R. van de Sande
4. Evaluation of the use of Easycare-TOS in cancer patients.
4.1. there will be measurement of acceptability of Easycare-TOS among GPs
4.2. Data from the first step of Easycare-TOS will be compared with data from
two screening tools used in oncology (G8 and GFI), and data from a limited CGA
(including IADL, GDS and MNA) The Easycare-Tos will be performed before start
of treatment by the GP and the screening tools and CGA by the oncology nurse
before start of treatment.
5. Exploring patient preferences on care by hospital nurse, POH, district nurse
and the use of internet.
Study design
1. After the first consultation of older patients with cancer who are planned
to start with systemic therapy, patients will be informed to participate in
this project.
2. After giving informed consent, the GP will be contacted and informed about
the treatment goals and toxicity. Information from the GP will be obtained,
according to the Easycare-TOS (first step).
3. Patients will be informed by the oncology nurse about their treatment and
possible side effects. Information about *Hereismydata ** will be given.
4. A limited CGA, including (G8, GFI, IADL, GDS and MNA) will be performed by
the trained oncology nurse.
5. For the MST patients, they will be visited by the oncology nurse at home,
preferably in cooperation with the regular home care team and a team member of
the GP. Emphasis will be put on toxicity items, and *Hereismydata ** use. For
the UMCN patients, the oncology nurse will inform the CP team and the home care
team by telephone. There will be one person in primary care which serves as the
first partner responsible for maintaining links in primary care (POH or home
care team member) and the oncology nurse will be coordinator of care in
hospital.
6. Patients will be asked to use *Hereismydata * every two days for the first
cycle of treatment. For patients without internet access caregivers (e.g.
children) will be asked to fill in the data, and if using internet is not
possible at all there will be regulary telephonic contact by the oncology
nurse. The oncology nurse will contact the first partner in primary care if
necessary.
7. In case of toxicity outside office hours, patients will contact the hospital.
8. Data will be analyzed regarding UHA.
9. Data will be analyzed regarding feasibility of Easy-TOS in patients
scheduled for systemic therapy and these data will be compared with those of
the screening tools and from CGA
10. Data will be analyzed regarding PROM, measurement will performed before
start of treatment, after cycle one and every 3 months thereafter. Specific
questionnaires are to be determined, but most likely will include
EORTC-QLQ-C30, EQ-D5, and/or the CQ index care for cancer patients which
currently is under development.
11. Data will be analyzed regarding satisfaction among GPs and home care teams
12. A teaching module will be developed regarding recognition and treatment of
sided effects of systemic cancer therapy, for use in primary care settings.
Study burden and risks
The burden for the patients is mainly related to time required for filling in
the questionnaires.
For treatment starts, this will include about 30-45 minutes; after 2 cycles and
3 months after treatment finished this will take about 15 minutes.
During treatment there will be more frequently contacts with the oncology nurse
The benefit could be that patient experience more intensive monitoring (and
better treatment of side-effect and less hospitalizations)
Ariënsplein 1
Enschede 7511 JX
NL
Ariënsplein 1
Enschede 7511 JX
NL
Listed location countries
Age
Inclusion criteria
treatment with chemotherapy/targeted therapy
aged 70 years or older
signed informed consent
Exclusion criteria
insufficient command on the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL48682.044.14 |
Other | volgt |
OMON | NL-OMON24734 |