Self-management Support in Cancer Pain
Primary Purpose
Pain
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Self-management support
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Cancer pain, Self-management, Randomized controlled trial
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
Sites / Locations
- Atrium Medical CenterRecruiting
- Maastricht University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Self-management support
Care as usual
Outcomes
Primary Outcome Measures
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
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)
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Secondary Outcome Measures
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
As measured with the Chronic Pain Self-efficacy Scale (CPSS)
Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
As measured with the Pain Knowledge Questionnaire (PKQ)
Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
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)
As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview
Full Information
NCT ID
NCT02333968
First Posted
December 29, 2014
Last Updated
January 7, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Atrium Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02333968
Brief Title
Self-management Support in Cancer Pain
Official Title
Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Atrium Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Cancer pain, Self-management, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Self-management support
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Self-management support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
Description
As measured with the Brief Pain Inventory - Short Form (BPI-SF)
Time Frame
12 weeks
Title
Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Description
As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
Description
As measured with the Chronic Pain Self-efficacy Scale (CPSS)
Time Frame
12 weeks
Title
Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
Description
As measured with the Pain Knowledge Questionnaire (PKQ)
Time Frame
12 weeks
Title
Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
Description
As measured with the Hospital Anxiety and Depression Scale (HADS)
Time Frame
12 weeks
Title
Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
Description
As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Hochstenbach, MSc
Phone
+31 433881691
Email
l.hochstenbach@maastrichtuniversity.nl
Facility Information:
Facility Name
Atrium Medical Center
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asiong Jie, MD, PhD
Phone
+31 455766666
Email
G.Jie@atriummc.nl
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemie Courtens, PhD
Phone
+31 433877548
Email
a.courtens@mumc.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
25986294
Citation
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.
Results Reference
derived
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Self-management Support in Cancer Pain
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