Pain
Conditions
Keywords
Cancer pain, Self-management, Randomized controlled trial
Brief summary
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess 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, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.
Interventions
BEHAVIORALSelf-management support
The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses. Every morning and evening patients register pain and related symptoms by use of a pain diary. Patients are also requested to register medication intake. Graphical feedback is provided based on registered pain scores and medication intakes. Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain. Patients communicate with nurses via text message functionality within the application. Specialized nurses remotely monitor and analyze the patients' situation once every workday. Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.
Sponsors
Atrium Medical Center
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 of 4 or more on a numerical rating scale (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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF) | 12 weeks | As measured with the Brief Pain Inventory - Short Form (BPI-SF) |
| Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3) | 12 weeks | As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ) | 12 weeks | As measured with the Pain Knowledge Questionnaire (PKQ) |
| Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS) | 12 weeks | As measured with the Hospital Anxiety and Depression Scale (HADS) |
| Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview) | 12 weeks | As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview |
| Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS) | 12 weeks | As measured with the Chronic Pain Self-efficacy Scale (CPSS) |
Countries
Netherlands
Contacts
Primary ContactLaura Hochstenbach, MSc
Outcome results
None listed