PRIMARY OBJECTIVE: to evaluate the effectiveness of the GerOnTe, ICT-based, integrated care pathway to improve patient 6-month quality of life, in Belgium and the Netherlands.SECONDARY OBJECTIVES• Evaluate the effectiveness of the GerOnTe patient-…
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Brief title
Condition
- Other condition
Synonym
Health condition
Borst-, long-, prostaat- en colorectale kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY ENDPOINT
Quality of life assessed by the EORTC QLQ-C30 questionnaire at 6 months after
GerOnTe inclusion using 3 derived scores of the QLQ-C30 questionnaire:
• Normalized global health status score
• Normalized score of the physical functioning scale
• Normalized score of the emotional functioning scale
Secondary outcome
SECONDARY ENDPOINTS
1. Quality of life
• The 3 normalized QLQ-C30 scores at baseline 3, 9 and 12 months
• Normalized scores of QLQ-C30 scales/items (role functioning scale, cognitive
functioning scale, social functioning scale, fatigue scale, nausea scale, pain
scale, dyspnea item, insomnia item, appetite loss item, constipation item,
diarrhea item and financial difficulties item) at baseline, 3, 6, 9 and 12
months.
• Scores of QLQ-ELD14 scales/items (mobility scale, worries about others scale,
future worries scale, maintaining purpose scale, burden of illness scale, joint
stiffness item, family support item) at baseline, 3, 6, 9 and 12 months
2. Survival: Overall survival at 12 months and progression-free survival (the
time from study treatment initiation to the first occurrence of disease
progression or death, whichever occurs first).
3. Patient autonomy, frailty and weight evolution
• Dependence score of the Activities of Daily Living scale (Katz ADL) at
baseline, 3, 6, 9 and 12 months,
• Proportion of patients living at home at 6 and 12 months,
• Number of completed chair stands in 30 seconds (Chair stand test) at
baseline, 3, 6, 9 and 12 months,
• Score of the Clinical Frailty Scale at baseline, 3, 6, 9 and 12 months,
• Grade of performance status, measured by ECOG-PS at baseline, 3, 6, 9 and 12
months,
• Weight at baseline, 3, 6, 9 and 12 months.
4. Patient anxiety: Score of Hospital Anxiety and Depression Scale (HADS) at
baseline, 3, 6, 9 and 12 months.
5. Proportion of patient institutionalized and number of unscheduled
hospitalisations per participants at 6 and 12 months.
6. Cost per life years gained (CEA, derived from survival/progression-free
survival), cost per QALY gained (CUA, using utility assessed through normalized
scores of EQ-5D-5L questionnaire collected at baseline, at 3, 6, 9 and 12
months after inclusion) and incremental cost-effectiveness ratios (ICERs)
obtained by a cost-utility and a cost-effectiveness analysis.
7. Caregiver burden in health, psychological well-being, finances, social life
and relationship with patient, using the Zarit Burden Interview at baseline, 3,
6, 9 and 12 months
8. Patient reported overall experience of person-centred coordinated care
measured through the Person-Centred Coordinated Care Experience Questionnaire
(P3CEQ) at 6 and 12 months.
9. Patient, physician and health-care-professionals-reported overall
satisfaction with the ICT of the GerOnTe system: Score derived from the mHealth
App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the
patient version for patient satisfaction and the provider version for physician
and health care professional at 6 and 12 months after inclusion.
10. GerOnTe patient-centred system implementation and usage evaluated at 6
months (use of the Holis Patient App measures, for instance: number and
frequency of connections to the app by patients; number of web-based meetings
with APN by site)
Background summary
The heterogeneity of older patients in terms of health status, physical
functioning and intrinsic capacity makes their evaluation complex. In those
aged 65 to 84, the proportion of patients with multimorbidity is as high as 65%
and rises to 81% in those aged 85 or older. Currently, in Europe,
acute-hospital care is mainly single-disease oriented. As a result, coexisting
morbidities are often under-evaluated and under-managed, leading to
inappropriate drug prescriptions, avoidable hospital admissions, delays in
treatment and ultimately to suboptimal care and unnecessary cost overruns.
Moreover, because of different health organisations, management of older
multimorbid patients varies from one country to the other while we know that
the structure of health system organisation has a strong impact on patients*
health status. Finally, none is currently structured to absorb the demographic
increase of older patients.
People with multimorbidity have reduced quality of life and impaired health
outcomes and experience a significant impact of disease burden and an increased
risk of death that current disease-centred management, which impacts patients*
quality of life and quality of care, cannot manage.
Disease-centred approach is not appropriate to manage these patients. Change to
a patient-centred approach will simplify care pathways, secure management and
treatment decision making and decrease healthcare costs. It will be a real
breakthrough for daily practice with multiple impacts that must be quantified.
The clinical model behind GerOnTe is to regroup all health professionals taking
care of a multimorbid patient, into a common care coordination pathway: the
Health Professional Consortium (HPC). The HPC will (i) centralise the
decisions, aligning them to the patient*s priorities, (ii) be assisted by an
advanced practice nurse (APN) as case manager, and (iii) be facilitated by
HolisTM GV data exchange, personalised for each patient. Patients will be
stratified in order to determine their dominant disease, thus the appropriate
HPC. Patient-centred health management by the HPC with availability of real
time, hospital- and patient-based data will foster timely decision enabling
avoidance of unnecessary procedures and treatments leading to reduction in
number of ineffective treatments, complications and unscheduled
hospitalisations, concerted treatments of multimorbidities, and to more
patients staying at home thanks to self-management related reduction of
dependence.
The whole approach will be co-designed with patients, informal care givers and
health professionals. Cancer is an excellent model to develop this approach in
multimorbid patients because it is frequent and commonly associated with other
morbidities in older patients but also because of its major impact on patients*
general status and coexistent diseases. Cancer already benefits from a
multidisciplinary management model that GerOnTe will enhance, strengthening
exchange of holistic data, role of primary care and case management. GerOnTe
will also provide new country-specific guidelines and best practices for
implementation across Europe and for improved management of older multimorbid
patients including improved quality of life and independent living at decreased
costs.
Study objective
PRIMARY OBJECTIVE: to evaluate the effectiveness of the GerOnTe, ICT-based,
integrated care pathway to improve patient 6-month quality of life, in Belgium
and the Netherlands.
SECONDARY OBJECTIVES
• Evaluate the effectiveness of the GerOnTe patient-centred system to:
o Improve quality of life at 3, 9 and 12 months,
o Improve patient survival and progression-free survival at 12 months,
o Improve patient autonomy at 3, 6, 9 and 12 months,
o Reduce patient anxiety at 3, 6, 9 and 12 months,
o Reduce patient unscheduled hospitalisations and patient institutionalisations
at 6 and 12 months,
• Assess the cost-utility and cost-effectiveness of the GerOnTe intervention
versus standard of care up to 1-year post-inclusion (3, 6, 9 and 12 months
after inclusion),
• Evaluate caregiver burden in health, psychological well-being, finances,
social life and relationship with patient at 3, 6, 9 and 12 months,
• Evaluate patient-reported overall experience of the GerOnTe intervention at 6
and 12 months,
• Evaluate patient and health care professionals reported overall satisfaction
and acceptability of the GerOnTe intervention at 6 and 12 months,
• Analyze the implementation and use of the GerOnTe patient-centred
intervention by patients and health care professionals
Study design
Study design is a stepped wedge randomized controlled trial. Clusters will be
participating hospitals, comprising eight investigating sites in total.
Patients included at each *step* are different individuals. The first *step* is
a reference measurement where none of the clusters will implement the
intervention. The investigating sites will be randomly drawn to determine the
order in which they will implement the intervention, by *steps* of two months.
Each centre engaged to participate needs to participate till the end of the
trial. A centre commitment to participate will be requested before each centre
involvement to avoid centre withdrawal after the start of the trial.
Intervention
The intervention will include the following components:
• A health professional consortium (HPC) for each patient, which will work
together to make recommendations regarding oncologic treatment and
non-oncologic interventions, at baseline and in the course of treatment. This
will be in addition to the usual multidisciplinary tumour board (MTB) which
will provide oncologic treatment recommendations based on the usual oncologic
work-up.
• An advance practice nurse (APN) as case-manager, who will be the primary
contact person for the patient during the oncologic treatment and subsequent
follow-up
• A baseline patient evaluation consisting of a comprehensive geriatric
assessment by a geriatrician or APN, which will focus on general health status,
comorbidities and intrinsic capacity. Baseline documentation of patient
preferences and priorities will be done by the APN.
• A health care professional dashboard called Holis Dashboard, which will
provide a structured presentation of patient and tumour information, both
during the decision-making phase as well as during treatment and follow-up,
according to the standard consensus dataset. Dashboard data will be made
available selectively to all health care professionals of the HPC.
• A patient application called Holis Patient Application, which will allow for
monitoring of symptoms and signs of destabilised comorbidity or functional
decline during and after treatment, with additional self-management library
with recommendations for how the patient can deal with issues or for contacting
their health care providers in case of symptoms requiring urgent intervention.
• Additional data that will be collected every 3 months are quality of life
questionnaires (EORTC QLQ-C30/QLQ-ELD14/EQ-5D-5L), autonomy questionnaire (Katz
ADL), anxiety/depression questionnaire (HADS), patient-related outcomes
questionnaire (perceived benefit, treatment objectives, tool satisfaction) and
possible revision of patient*s treatment objectives.
Study burden and risks
Very minimal risks to the patient. Possible increased focus on side effects due
to daily use of HolisTM GV Patient App which may cause anxiety.
Herestraat 49
Leuven 3000
BE
Herestraat 49
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
General inclusion criteria
1. Age >= 70 years old.
2. New or progressive cancer (breast, lung, colorectal, prostate) fulfilling
the tumour specific criteria.
3. Estimated life expectancy greater than 6 months.
4. At least one moderate/severe multimorbidity inclusion criteria other than
current cancer (see separate list under 5.3).
5. Patients must be willing and able to comply with study procedures.
6. Voluntarily signed and dated written informed consents prior to any study
specific procedure.
7. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before
inclusion.
Tumour specific inclusion criteria
8. Specific inclusion criteria for breast cancer:
8.1. Non-metastatic breast cancer (M0):
• No prior treatment for the current breast cancer.
• All 3 criteria required:
o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3,
o The cancer specialist considers* surgery,
o The cancer specialist considers* radiotherapy and/or chemotherapy.
8.2. Metastatic breast cancer (M1): Both criteria required:
• The cancer specialist considers* chemotherapy or PARP-inhibitors or
mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6
inhibitors is allowed,
• The patient received maximum 1 prior line of chemotherapy for metastatic
disease.
**consider* implies that this treatment may be a treatment option for this
patient in this particular setting. If at a later point, a different treatment
choice is made, the patient remains eligible.
9. Specific inclusion criteria for colorectal cancer:
9.1. Non-metastatic colorectal cancer (M0):
• No prior therapy for the current tumour in the recruiting hospital.
• At least one of the 3 criteria required:
o The cancer specialist considers* surgery,
o The cancer specialist considers* radiotherapy,
o The cancer specialist considers* chemotherapy.
9.2. Metastatic colorectal cancer (M1):
• The cancer specialist considers* first line systemic therapy and/or
radiotherapy (+/- surgery). No previous chemotherapy allowed except
adjuvant/perioperative chemotherapy stopped for more than 12 months.
**consider* implies that this treatment may be a treatment option for this
patient in this particular setting. If at a later point, a different treatment
choice is made, the patient remains eligible.
10. Specific inclusion criteria for lung cancer:
10.1. Non-metastatic lung cancer (M0):
• No prior therapy for the current tumour in the recruiting hospital
• At least one of the 3 criteria required:
o The cancer specialist considers* surgery (patients considered for treatment
with percutaneous thermoablation alone are not eligible),
o The cancer specialist considers* radiotherapy (except SBRT),
o The cancer specialist considers* systemic therapy. Possible systemic
therapies are chemotherapy and/or immune therapy and/or targeted therapy.
Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin
analog are not eligible.
10.2. Metastatic lung cancer (M1):
• The cancer specialist considers* first or second line systemic therapy.
Possible systemic therapies are chemotherapy and/or immune therapy and/or
targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI
or somatostatin analog are not eligible.
**consider* implies that this treatment may be a treatment option for this
patient in this particular setting. If at a later point, a different treatment
choice is made, the patient remains eligible.
11. Specific inclusion criteria for prostate cancer:
11.1. Non-metastatic prostate cancer (M0): one of the following:
• First diagnosis M0 prostate cancer (no therapy received yet for prostate
cancer): at least one of the 2 criteria required:
o The cancer specialist considers* radiotherapy,
o The cancer specialist considers* hormone therapy (ADT +/- combination
Abiraterone and Prednisone).
• Salvage treatment M0 prostate cancer (received prior surgery at least 6
months before):
o The cancer specialist considers* radiotherapy (+/- ADT)
• Non-metastatic castration resistant prostate cancer:
o The cancer specialist considers* treatment intensification (ADT +
Enzalutamide or Apalutamide or Darolutamide).
11.2. Metastatic prostate cancer (M1):
• The cancer specialist considers* treatment with Abiraterone or Enzalutamide
or Apalutamide or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA.
**consider* implies that this treatment may be a treatment option for this
patient in this particular setting. If at a later point, a different treatment
choice is made, the patient remains eligible.
Protocol: page numbers 24-28
Exclusion criteria
1. Mental illness/cognitive impairment that limits ability to provide consent
or complete trial procedures.
2. Participating to an interventional clinical trial with a non-registered
anticancer drug or to another geriatric intervention trial.
3. Patients and caregivers are unable or unwilling to use ICT-devices (tablet,
computer, smartphone) or the Internet according to protocol.
4. Patient already included in this study.
Protocol: page number 26
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05423808 |
| CCMO | NL81897.100.22 |