Self-management Support in Cancer Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Self-management support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Self-management support | Behavioral: Self-management support<br>* 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.<br>|
| No Intervention: Control group<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF) | As measured with the Brief Pain Inventory - Short Form (BPI-SF) | 12 weeks | 
| Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3) | As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS) | As measured with the Chronic Pain Self-efficacy Scale (CPSS) | 12 weeks | 
| Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ) | As measured with the Pain Knowledge Questionnaire (PKQ) | 12 weeks | 
| Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS) | As measured with the Hospital Anxiety and Depression Scale (HADS) | 12 weeks | 
| Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview) | As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer pain, Self-management, Randomized controlled trial