Self-management Support in Cancer Pain

Not Applicable

• Conditions: Pain
• Interventions: Behavioral: Self-management support

• Registration Number: NCT02333968
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-12-29
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-07
• Last Update Submitted: 2015-01-07
• Study First Posted: 2015-01-08
• Last Update Posted: 2015-01-08
• Primary Completion: 2015-06
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Self-management support	Self-management support

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)	12 weeks	As measured with the Chronic Pain Self-efficacy Scale (CPSS)
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

Trial Locations

Locations (2)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Atrium Medical Center; 🇳🇱 Heerlen, Netherlands