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Self-management Support in Cancer Pain

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ClinicalTrials.gov Identifier: NCT02333968
Recruitment Status : Unknown
Verified January 2015 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Collaborator:
Atrium Medical Center
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Self-management support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Study Start Date : February 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Self-management support
 Behavioral: Self-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.
No Intervention: Control group
Care as usual


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS) [ Time Frame: 12 weeks ]
    As measured with the Chronic Pain Self-efficacy Scale (CPSS)

  2. Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ) [ Time Frame: 12 weeks ]
    As measured with the Pain Knowledge Questionnaire (PKQ)

  3. Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ]
    As measured with the Hospital Anxiety and Depression Scale (HADS)

  4. Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview) [ Time Frame: 12 weeks ]
    As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333968


Contacts
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Contact: Laura Hochstenbach, MSc +31 433881691 l.hochstenbach@maastrichtuniversity.nl

Locations
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Netherlands
Atrium Medical Center Recruiting
Heerlen, Netherlands
Contact: Asiong Jie, MD, PhD    +31 455766666    G.Jie@atriummc.nl   
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Annemie Courtens, PhD    +31 433877548    a.courtens@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Atrium Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02333968    
Other Study ID Numbers: UM 2011-5079
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by Maastricht University Medical Center:
Cancer pain
Self-management
Randomized controlled trial
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations