The research objectives of this study are divided in a primary research objective and secondary research objectives.Primary:1. To study the effectiveness on the short and long term of patient-tailored interdisciplinary MSCR compared with AHC on the…
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Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life
Cancer-specific quality of life will be assessed using the EORTC QLQ-C30. The
EORTC QLQ-C30 is a reliable and valid instrument that has been used in many
studies evaluating clinical and psychosocial interventions in cancer patients.
The 30-item EORTC QLQ-C30 incorporates a global quality of life scale and five
functional scales, namely physical functioning, social functioning, role
functioning, emotional functioning, and cognitive functioning; and three
symptom scales, namely fatigue, pain, and nausea and vomiting. In this study,
we will report the results of the global scale, the functional scales, and one
symptom scale (i.e. fatigue) since these are the scales most relevant for
participants who have already completed primary treatment for cancer. After
applying a linear transformation procedure according to the EORTC QLQ C-30
manual, the scores of the scales range from 0 to 100. A higher score represents
a higher quality of life on the global and functional scales, and a higher
level of fatigue. In a previous study differences of at least ten points are
classified as a minimum clinically meaningful change.
Secondary outcome
Costs
During the study period (12 months), all participants will fill out
questionnaires to assess their healthcare resource use, work status and
productivity losses. Data on health care costs, patient and family costs will
be collected using the Medical Consumption Questionnaire (iMCQ) on a 3-monthly
basis. Health care costs include the costs of oncological care, general
practice care, paramedic care, additional visits to other health care
providers, prescription of medication, professional home care and
hospitalization. Patient and family costs include out-of-pocket expenses such
as travel expenses, over-the-counter medication, and costs for paid and unpaid
help. Units resource use (GP visits, hospital days, etc.) will be multiplied by
their appropriate integral cost prices. The EuroQuol-5D-5L (EQ-5D-5L) will be
used to calculate quality-adjusted life years (QALYs) and consists of the EQ-5D
descriptive system and the EQ VAS. The EQ-5D descriptive system comprises five
health dimensions (mobility, self-care, usual activities, pain/discomfort,
anxiety/depression). Each dimension comprises five levels (no problems, some
problems, moderate problems, severe problems and extreme problems). The EQ VAS
records the respondents* self-rated health status on a vertical graduated
(0-100) visual analogue scale. An economic evaluation regarding work/work loss
and health care use will be conducted as a cost-utility analysis for
health-related quality of life (and changes therein) as assessed using the
EQ-5D. Indirect non-medical cost data related to production losses through work
loss days and work cutback days will be sampled with the Productivity Costs
Questionnaire (iPCQ) for the measurement (and valuation) of productivity costs.
It has been tested in several Dutch samples of patients and workers. The
modular questionnaire covers all relevant aspects of the relationship between
health and productivity, including absence from work, compensation mechanisms
that may reduce productivity loss, reduced productivity at work (efficiency
losses) and productivity costs at the level of organizations. Indicators of
return to work (RTW) are time to partial and to full RTW, meaning the number of
calendar days between end of treatment and first day at work, and time to full
RTW corrected for partial RTW.
Fatigue
For the assessment of fatigue, we will use the Dutch version of the MFI
Multidimensional Fatigue Index (MFI). It contains 20 questions on the following
domains: general fatigue, physical fatigue, mental fatigue, loss of motivation
and reduced activities. The psychometric properties of the MFI have been tested
in cancer patients undergoing chemotherapy and radiotherapy. Internal
consistency of the separate scales was good in a Dutch samples with Cronbach's
alpha coefficients ranging from 0.79 to 0.93. Construct validity was assessed
by correlating the MFI-20 to activities of daily living, anxiety and
depression. Significant relations were assumed. Convergent validity was
investigated by correlating the MFI scales with a visual analogue scale
measuring fatigue and with a fatigue-scale derived from the Rotterdam Symptom
Checklist. Results support the validity of the MFI-20.
Physical fitness
Cardiorespiratory fitness will be measured using a cardiopulmonary exercise
test on a bicycle ergometer with expiratory gas analysis. Cardiorespiratory
fitness is expressed as maximum oxygen uptake per minute in milliliters per
kilogram body weight (ml/min/kg) and the maximum workload (W). During the test,
participants are asked to cycle constantly at 60-65 rounds per minute (rpm).
Gas exchange is measured using a breath-by-breath gas analysis system. At the
start of the test expiratory gas analysis is performed in participants at rest
for three minutes. Subsequently, participants start cycling with a workload of
20 watts. The workload increases stepwise every minute by 10, 15, 20 or 25
watts, depending on the participant*s fitness, whereby the test should last
between 10 and 15 minutes. During the test, the participant is encouraged to
keep going by the physician. The test is completed when the participant no
longer able to maintain the prescribed rate of 60-65 rpm due to exhaustion. For
safety, blood pressure, heart rate and heart rhythm are monitored. The test is
discontinued in the event of clinical symptoms or intervention by the physician
(e.g. in case of ECG abnormalities, severe dyspnea, excessive increase in blood
pressure).
Aerobic capacity and endurance will be assessed using the six-minute walk test
(6MWT). The test has been used in a variety of chronic disease in adult and
pediatric populations as well as in healthy adults. Muscle strength will be
determined by means of the 1-RM test of the quadriceps and biceps muscles using
a handheld dynamometer and leg press (Micro Force Evaluating & Testing, Hoggan
Health Industries Inc., USA). All measurements will be performed at least three
times. The peak forces will be recorded and the mean values analyzed.
Psychological distress
Two questionnaires will be used to assess psychological distress. First,
participants will fill out the Center for Epidemiologic Studies Depression
Scale (CES-D), which is a brief self-report questionnaire that measures
depressive symptoms in the general population. The CES-D consists of 20
questions about various symptoms of depression as experienced in the past week.
It consists of four subclasses: depressive affect, somatic symptoms, positive
affect, and interpersonal relations. The CES-D has excellent psychometric
properties and is sensitive to changes over time in cancer patients. Second, to
assess symptoms of fear in participants, we will use the State Trail Anxiety
Inventory (STAI). This questionnaire contains 20 items divided over two
subscales and can measure anxiety at both poles of the normal affect curve
(state vs. trait).The STAI can be administered across a range of socio-economic
status levels and requires a reading age no higher than 12 years. The Dutch
version has been validated and has good psychometric properties.
Physical activity levels
Physical activity will be measured by accelerometer and a questionnaire. An
accelerometer is a small lightweight physical activity monitor (Actigraph GT9X
Link). Participants will be instructed to wear the accelerometer for seven
consecutive days following their baseline and follow-up measurements.
Accelerometry has been shown to be a reasonably valid method for objectively
assessing physical activity in adults.(38) Raw accelerometer data are converted
into counts, which are subsequently used to quantify time spent in sedentary
behavior, light-, moderate- and vigorous-intensive physical activity. The
SQUASH (Short Questionnaire to Assess Health-Enhancing Physical Activity) is a
commonly used instrument in the Netherlands to assess physical activity. It was
developed by the Dutch National Institute of Public Health and the Environment
(RIVM) to measure physical activity with respect to occupation, leisure time,
household, transportation means and other daily activities. The SQUASH was
designed to give an indication of the habitual activity level and was
structured in such a way that it would be possible to assess compliance to
physical activity guidelines. It has been shown to be valid in measuring
physical activity among the Dutch population.
Societal and work participation
Participants will fill out the Utrecht Scale for Evaluation of
Rehabilitation-Participation (USER-P). This questionnaire is about daily life
and consists of four parts: time spent on working, studying and attending to
household duties; performance of certain activities; experiencing restrictions
in daily life; and satisfaction with daily life. The USER-P appears to be a
valid measure to rate objective and subjective participation in persons with
physical disabilities. The following items will also be registered to determine
work reintegration:
- employment prior to diagnosis
- duration of absence from work (paid or unpaid)
- adjustment of working hours after treatment
- reintegration to similar or different work
Adherence to the program
Participants in both groups will be asked to fill out a rehabilitation log. The
time to fill out this log will be less than one minute, only on therapy days.
From the registration systems of the AHC professionals and the rehabilitation
center the actual attendance rate of the participant can be scored. Adherence
to the MSCR program will additionally be assessed by contacting the
specialists in Rehabilitation Medicine of the patients. Adherence to AHC will
be done by contacting the AHC professionals and the specialized oncological
nurse of the included patients. Health care uptake is also included in the IMCQ
questionnaires.
Background summary
Improvements in the screening, early detection, and effective treatment of
cancer has led to a rapid increase in the numbers of cancer survivors (1).
Cancer survivors suffer from a range of adverse effects that may include
fatigue, pain, reduced physical fitness, anxiety and depression * all of which
impair quality of life, reduce function in activities of daily living, and
hinder work participation. Given the current and expected numbers of cancer
survivors, this poses a serious public health problem. For example, in 2005,
22,000 persons in the Netherlands were considered unfit for work due to a
current or past diagnosis of cancer.
In the Netherlands, patients with cancer have several options for
rehabilitation. One of these options is to receive therapy from allied health
care(AHC) professionals. Often advised by oncological nurses, or general
practitioners or self-referral, patients visit individual physiotherapists,
psychologists, dieticians or other AHC professionals. A second option is to
rehabilitate at an interdisciplinary medical specialist rehabilitation facility
where patients receive patient-tailored interdisciplinary rehabilitation. The
goal of both interventions is to support patients in overcoming the adverse
effects of cancer and its treatment, and to improve their health-related
quality of life. Previous studies in patients with cancer have shown that
physical exercise is effective in alleviating fatigue, reducing depression and
improving physical fitness, muscle strength and health-related quality of life
Other studies have shown that psycho-education and cognitive behavioural
therapy (CBT) can be effective in reducing fatigue, depression and anxiety.
Combined interventions * usually a combination of exercise and psycho-education
or CBT * have also been shown to improve quality of life and physical fitness
and to reduce fatigue. A combination of interventions, tailored to the
patient*s individual needs, may optimize the quality of life of cancer
patients. To improve the quality of cancer rehabilitation in the Netherlands,
the clinical practice guideline *Cancer Rehabilitation* was first developed in
2011 and adopted by the Netherlands Society of Rehabilitation Medicine. In
subsequent years, the guideline was revised and given the title *Medical
Specialist Rehabilitation in Oncology*. It is a product of the Netherlands
Comprehensive Cancer Organization and published on the Oncoline website. The
goal of this guideline is to ensure that every patient experiencing physical
and psychosocial problems due to the cancer and cancer treatment receives
timely referral for adequate rehabilitation care. For patients with complex and
coherent multiple problems, referral to a specialist in rehabilitation medicine
is indicated so that they can participate in an interdisciplinary MSCR program.
For patients after completing the curative treatment limited evidence-based
recommendations are included in the guideline. The guideline recommends that an
MSCR program is patient-tailored and that it includes an aerobic and
progressive resistance training program of at least moderate intensity. It also
recommends CBT for survivors who are still fatigued one year after finishing
curative treatment.
Since the numbers of cancer survivors are increasing, and cancer care needs to
be kept affordable, economic evaluations of effective interventions are of
importance to guide decision-making. Studies that have addressed the
cost-effectiveness of cancer rehabilitation are limited in number and have
several drawbacks: they are heterogeneous in design, are not representative of
the MSCR program as described in the Dutch guideline, were performed mainly in
other countries, and have had contradicting results. In parallel, societal
costs can be reduced by providing patients with suitable rehabilitation to
alleviate the adverse effects of cancer. However, health budgets are under
pressure, and for wide acceptance of rehabilitation and after care programs for
cancer patients in society, it is important to know whether or not such
programs are cost-effective. In the Netherlands, the MSCR program has been
reimbursed by basic health care insurance since 2011. Other types of care that
patients may be referred to in AHC, such as physiotherapy or psychotherapy, are
not always covered by basic health care insurance, and patients often have to
finance this care themselves.
Despite the fact that multidisciplinary rehabilitation programs are
increasingly being recommended in (inter)national guidelines, evidence for the
effectiveness of such programs is scarce. Until now it is not known whether an
MSCR program that follows the Dutch guideline has a positive effect on the
health, quality of life, activities in daily life and societal and work
participation of cancer survivors and if the MSCR program is more effective
than AHC. The federation of rehabilitation (VRA) acknowledged this as a major
knowledge gap and research priority. It is also unknown what the costs of MSCR
are relative to AHC. In addition, no evidence exists on the long-term
differences in outcomes of both interventions.
Study objective
The research objectives of this study are divided in a primary research
objective and secondary research objectives.
Primary:
1. To study the effectiveness on the short and long term of patient-tailored
interdisciplinary MSCR compared with AHC on the quality of life in patients
with complex adverse effects due to cancer.
Secondary:
2 To study the cost-effectiveness of patient-tailored interdisciplinary MSCR
when compared with AHC.
3 To study the effect of patient-tailored interdisciplinary MSCR in terms of
fatigue, physical fitness, psychological distress, activity level, return to
work and societal participation when compared with AHC.
4. To study the adherence to both the MSCR and AHC group.
Study design
We will perform a multicentre prospective randomized controlled trial with two
arms: one arm will receive MSCR, while the other arm will receive AHC.
Intervention
MSCR group
Participants will follow a MSCR program according to the guideline. In this
guideline, it is recommended that a patient-tailored treatment program is
determined for each patient, taking into account the characteristics of the
disease and the preferences and personal goals of the patient. The
rehabilitation program can consist of the following interventions: physical
exercise training, coaching in energy distribution, psychosocial intervention,
dietary advice, and advice on work reintegration. In the guideline no advice is
given on the durationof the rehabilitation program. Generally, in a period of
12 weeks the individual goals of MSCR are reached. For each intervention a more
extensive description, including goals, in- and exclusion criteria, is
available.
AHC group
Patients in the AHC group will receive patient-tailored care by AHC
professionals who are experienced and preferably certified for treating cancer
patients. The AHC that will be given is a combination of therapies consisting
of physiotherapy, psychology and/or dietetics. The patient will be contacted by
the oncological nurse for further coordination. The oncological nurse will also
monitor the progress of the patients during the program. Health care that is
not covered under health insurance (physiotherapy) will be reimbursed. Health
care uptake will be closely monitored by the researcher, by contacting the
health care professionals and monitoring the IMCQ questionnaires.
Study burden and risks
All participants will fill out 8 questionnaires and will visit the study
centers for assessment of 3 performance tests. The questionnaires can be filled
out in 45 minutes, online or in the rehabilitation institution. In total the
questionnaires are filled out four times, except for the cost questionnaires
(EuroQol-5D-5L, IMCQ, IPCQ) that are filled out five times. The total time
needed to complete the performance tests is one hour at baseline and at 12
weeks. At 6 and 12 months the performance tests can be done in 15 minutes,
since a maximum exercise test is only performed at baseline and at 12 weeks. In
case of abnormalities on the maximum exercise test participants are referred to
a cardiologist. Risk that a SAE will occur is not higher than in care as usual.
Participants in both groups can benefit from participating in the study when
the program results in better physical fitness, more emotional balance, less
fatigue or other benefits. In addition, the rehabilitation program can support
the participants in maintaining a healthy and physically active life style.
Participants in the AHC group are excluded from a MSCR program for a time
period of 6 months. After this period, participants will be allowed to
participate in a rehabilitation program if the participant still meets all the
inclusion criteria of MSCR..
Dilgtweg 5
Haren 9750 RA
NL
Dilgtweg 5
Haren 9750 RA
NL
Listed location countries
Age
Inclusion criteria
- adults older than 18 years
- primary treatment with curative intent was finished less than 12 months ago
(adjuvant hormonal or is allowed)
- types of cancer: breast, prostate, lymphoma, gynecological, colorectal
- complex adverse effects of cancer or cancer treatment as determined using the
Lastmeter
Exclusion criteria
- serious diseases that might hamper a patient*s capacity to carry out
intensive exercise (e.g. severe heart failure: New York Heart Assaciation
(NYHA) criteria class 3 & 4 and COPD Gold 3 & 4)
- severe psychopathology
- patients who are undergoing primary or palliative cancer treatment
- inability to understand the Dutch language
- patients who finished their cancer treatment more than 12 months ago
Design
Recruitment
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 |
|---|---|
| CCMO | NL71960.042.20 |
| Other | NL7888 |