Self-management Support in Cancer Pain
Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
1 other identifier
interventional
174
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2014
Typical duration for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 8, 2015
January 1, 2015
1.3 years
December 29, 2014
January 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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 Arms (2)
Intervention group
EXPERIMENTALSelf-management support
Control group
NO INTERVENTIONCare as usual
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Atrium Medical Centercollaborator
Study Sites (2)
Atrium Medical Center
Heerlen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Related Publications (1)
Hochstenbach LM, Courtens AM, Zwakhalen SM, van Kleef M, de Witte LP. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol. BMC Cancer. 2015 May 19;15:416. doi: 10.1186/s12885-015-1428-1.
PMID: 25986294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2014
First Posted
January 8, 2015
Study Start
February 1, 2014
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
January 8, 2015
Record last verified: 2015-01