Clinical trial NCT02333968: Self-management Support in Cancer Pain
Official title: Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Cancer pain
Self-management
Randomized controlled trial
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Atrium Medical Center
First posted: 2015-01-08
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: 12 weeks
measure: Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
timeFrame: 12 weeks
measure: Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
timeFrame: 12 weeks
measure: Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
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.