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Clinical Trials/NCT02333968
NCT02333968
Unknown
Not Applicable

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

Maastricht University Medical Center2 sites in 1 country174 target enrollmentFebruary 2014
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Maastricht University Medical Center
Enrollment
174
Locations
2
Primary Endpoint
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
August 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)

Time Frame: 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)

Time Frame: 12 weeks

As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)

Secondary Outcomes

  • Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)(12 weeks)
  • Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)(12 weeks)
  • Change in anxiety and depression (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)(12 weeks)

Study Sites (2)

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