The aim of this study is to evaluate the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, depression and anxiety, and…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the effect evaluation are pain intensity and quality of
life.
- Pain intensity is measured with the Brief Pain Inventory (BPI), an instrument
frequently used to monitor pain in the clinical and research setting (Cleeland
1994; Jensen, 2003).
- Quality of life is measured with the EORTC Quality of Life Questionnaire
(EORTC-QLQ-C30 version 3). This instrument is cancer specific,
multi-dimensional and appropriate for self-administration. The EORTC-QLQ-C30
has shown acceptable levels of reliability and validity (Aaronson et al.,
1993).
Secondary outcome
Secondary outcomes measures for the effect evaluation include self-efficacy,
knowledge, anxiety and depression, and medication use.
- Self-efficacy is measured with the Chronic Pain Self-efficacy Scale
(CPSS-DLV). The Dutch language version of the CPSS has two subscales (pain and
symptom management and physical functioning), each consisting of 10 items.
Patients score the items on a 10-100 scale, 10 representing very unsecure and
100 very secure. Reliability and validity have been demonstrated for different
pain conditions (Köke, unpublished).
- Ferrell*s Patient Pain Knowledge Questionnaire (PKQ-DLV) will be used to
measure knowledge. The questionnaire includes eight items that will be
transformed to a 0-100 scale (0 is the lowest knowledge score; 100 is the
highest knowledge score). The PKQ-DLV has an acceptable reliability and
validity (De Wit, 1999).
- Anxiety and depression will be measured with the Hospital Anxiety and
Depression Scale (HADS). The HADS showed good performance to assess symptom
severity, anxiety disorders (alpha 0.67-0.90) and depression (0.67-0.90) in
somatic, psychiatric and primary care patients, with a sensitivity and
specificity of approximately 0.80 (Bjelland et al., 2002; Spinhoven et al.,
1997)
- Information about medication use will be derived from the regular patient
passport of the pharmacist. Other demographic and medical data will be
collected at the first measurement and retrieved from the medical record.
The outcome measure for the economic evaluation is costs per QALY.
- Cost utility will be measured with the EuroQol (EQ-5D-5L). This is a
self-administered questionnaire which consists of five dimensions of
health-related quality of life (mobility, self-care, daily activity,
pain/discomfort and anxiety/depression). These dimensions can be added to
comprise an overall health state that will be translated to a utility. Utility
rates, derived from the Doran algorithm, will be used to compute QALY*s
(EuroQol Group, 2011).
- Cost-effectiveness evaluation includes costs of the intervention, healthcare
costs (referral to the hospital, outpatient clinic visits, visits to GP and
other physicians, contact with paramedics, psychologists), patient and family
costs (time, informal care, travel costs) and costs outside the health care
sector. Existing questionnaires will be combined to identify all relevant
costs. Valuation of costs will be based on the Dutch manual for cost analysis
in health care research (Oostenbrink et al., 2004).
The outcome measures for the summative process evaluation are use of the
intervention, satisfaction with the intervention, and the occurrence of nurse
interventions. These items will be discussed in semi-structured interviews with
intervention patients and health professionals.
Background summary
The prevalence of pain in patients with cancer is high (59% in patients on
active treatment, 64% in patients with advanced disease, 33% in patients who
have been cured). Pain has an enormous impact on functioning of patients and
may result in anxiety and depression. According to the three step WHO pain
ladder and national guidelines, adequate symptom relief should be accomplished
in 70-90% of patients with cancer. At present though, adequate pain control is
not being realized in 50% of the patients. Shortcomings in current pain
control, together with developments in demographics and health care,
necessarily imply that outpatients have to be involved more closely in their
own pain management. Technological possibilities might provide a solution.
In the first phase of the project a telemonitoring intervention has been
developed during which patient and professionals were closely involved. The
intervention aims at supporting patients in self-managing their pain by means
of pain and medication monitoring, feedback information, education and contact
with a specialized nurse. The pilot study (December 2012 * March 2013; 13
patients and 3 specialized nurses) provided insight into technical functioning,
usability, acceptability, comprehensiveness and feasibility of the
intervention. Accordingly, the intervention has been optimized.
Study objective
The aim of this study is to evaluate the effect of the intervention regarding
pain intensity and quality of life as compared to care as usual. Secondary
outcomes of the effect evaluation are self-efficacy, knowledge, depression and
anxiety, and medication use. Besides a cost evaluation and summative process
evaluation will be performed.
Study design
This study will be carried out in the regions of Maastricht Heuvelland and
Oostelijk Zuid Limburg, surrounding the MUMC+ and Atrium MC. The duration of
the study is twelve weeks for each individual patient. Randomisation will
assign patients to the intervention or control condition. The intervention
group receives the intervention. At the start, the nurse will visit these
patients at home to carry out a pain anamnesis and gives instructions about the
use of the iPad application. After the study the researcher visits the
intervention patients once more for a semi-structured interview. The control
group receives care as usual. Measurements for both groups will be carried out
at T0 (baseline), T1 (4 weeks), T2 (12 weeks) and consist of written
questionnaires.
Intervention
The system consists of an iPad application for the patient and a
web-application for the health professional (nurse and treating physician). The
applications are embedded in a health care organisation in which health
professionals involved cooperate to establish optimal pain treatment for their
patients. When a new patient is included in the intervention group the
pharmacist is informed and requested to provide a medication passport. The pain
medication from this passport is entered into the webbased application by the
nurse, which is checked by a second nurse. These data are translated into the
medication overview that is visible for patients in the iPad application.
Changes in pain medication during the study period are processed in the same
way.
Application patient: By means of an iPad application patients fill out twice
daily a number of questions about their pain (pain at this moment, number of
pain attacks, worst pain), other symptoms (including nausea, dizziness and
constipation), satisfaction with pain treatment, changes in prescription and
activity/sleep. In addition patients are requested to tick off medication that
is presented in an overview per point in time. The monitored data are sent
secured to the server. From that point the patient is provided with feedback
information (graphs) that provides insight into his or her own situation.
Education is part of the intervention as well. During participation in the
study the patient receives education topics several times about: causes of
pain, treatment of pain, medication facts and fiction, recognition of symptoms
that require action, and methods that patients themselves can implement to
control their pain and other symptoms. The education is based on and tested
during previous studies (De Wit et al., 1997; Van der Peet, 2009). Patients are
able to leave a message for the nurse.
Application health professional: The nurse receives a translation of the data
as well. He or she will enter the web-application by use of a log in name and
password once a day to monitor and analyse the pain and medication data. With
help of a decision support system, by orderly presenting and the use of
collared flags, nurses have quick insight into which patients need their
attention and action or posed a message. When needed nurse interventions can be
applied (feedback and advise via the iPad application, consultation by
telephone, a home visit, consultation with the pain specialist, discuss the
patient*s situation in the multidisciplinary team or advise to the treating
physician to change medication). When needed, the nurse discusses the patient
with the pain specialist. Accordingly, the nurse contacts the treating
physician to report the discussed advise. The treating physician decides on
whether or not to take the advice and therefore on follow-up. Via login data
the treating physician has access into the web-application and insight into the
data of own patients.
Study burden and risks
The risk that is associated with participation is minimal because the current
situation of the patient will be starting point for fine tuning the pain
treatment. The daily monitoring of patients could result in patients being
focused and possibly anxious by getting insight into their own situation. The
nurse will take care of this. Feelings of anxiety and focus on pain, as a
result of using the intervention, have not emerged in the pilot study.
Evaluations were mostly positive.
The benefit that opposes the burden mentioned above is that participants get a
detailed insight into their own course of pain and the relation between this
course of pain, their medication use and their sleep / activity patterns. By
means of the intervention, eventually patients are better able to cope with
their pain and other symptoms more adequately. Furthermore pain treatment can
be fine-tuned better and faster, by daily monitoring and assessment. Eventually
pain intensity scores should be lowered.
Duboisdomein 30
Maastricht 6229 GT
NL
Duboisdomein 30
Maastricht 6229 GT
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of cancer
- Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- Cancer (treatment related) pain > 2 weeks
- Pain is defined as a patient reported pain score * 4 on a numerical rating scale (NRS, scale 0-10)
- Living at home
Exclusion criteria
- Expected life expectancy < 3 months
- Chronic non-cancer pain
- Known cognitive impairments
- Participation in other studies that interfere with this study
- Not being able to read and understand the Dutch language
- Reduced vision
- Non-reachable by phone
Design
Recruitment
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL46552.096.13 |