Self-management Support in Cancer Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02333968
• Other study ID #: UM 2011-5079
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2014
• Last updated: January 7, 2015
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2015
• Source: Maastricht University Medical Center
• Contact: Laura Hochstenbach, MSc
• Phone: +31 433881691
• Email: l.hochstenbach[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Atrium Medical Center	Heerlen
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Atrium Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)	As measured with the Brief Pain Inventory - Short Form (BPI-SF)	12 weeks	No
Primary	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	No
Secondary	Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)	As measured with the Chronic Pain Self-efficacy Scale (CPSS)	12 weeks	No
Secondary	Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)	As measured with the Pain Knowledge Questionnaire (PKQ)	12 weeks	No
Secondary	Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)	As measured with the Hospital Anxiety and Depression Scale (HADS)	12 weeks	No
Secondary	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	12 weeks	No